A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Pregnancy Related Clinical Trial

Official title:

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06056635
• Other study ID #: IRB-P00044063
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2024
• Source: Boston Children's Hospital
• Contact: Brittany Gudanowski
• Phone: 617-919-6658
• Email: Brittany.Gudanowski[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.

Description:

The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes.

Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios.

This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant patient with a condition requiring in-utero surgery

• Patient must be eligible for anesthesia

• Patient and father of the fetus (if available) are able to provide signed informed consent

Exclusion Criteria:

• Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative

• Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy

• Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life

• Pre-pregnancy maternal BMI greater than 40

• High risk for fetal hemophilia

• Fetal aneuploidy or variants of known significance if an amniocentesis was performed

• Contraindication to abdominal surgery or fetoscopic surgery

Related Conditions & MeSH terms

• Fetal Conditions
• Fetofetal Transfusion
• Hemangioma
• Maternal; Procedure
• Pregnancy Related
• Syndrome
• Twin Monochorionic Monoamniotic Placenta
• Twin Reversal Arterial Perfusion Syndrome
• Twin to Twin Transfusion Syndrome
• Vasa Previa

Intervention

Device:
• Karl Storz Curved Scope
The curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.
• Karl Storz Straight Scope
The straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Middeldorp JM, Lopriore E, Sueters M, Klumper FJ, Kanhai HH, Vandenbussche FP, Oepkes D. Twin-to-twin transfusion syndrome after 26 weeks of gestation: is there a role for fetoscopic laser surgery? BJOG. 2007 Jun;114(6):694-8. doi: 10.1111/j.1471-0528.2007.01337.x. — View Citation

Papanna R, Block-Abraham D, Mann LK, Buhimschi IA, Bebbington M, Garcia E, Kahlek N, Harman C, Johnson A, Baschat A, Moise KJ Jr. Risk factors associated with preterm delivery after fetoscopic laser ablation for twin-twin transfusion syndrome. Ultrasound Obstet Gynecol. 2014 Jan;43(1):48-53. doi: 10.1002/uog.13206. — View Citation

Petersen SG, Gibbons KS, Luks FI, Lewi L, Diemert A, Hecher K, Dickinson JE, Stirnemann JJ, Ville Y, Devlieger R, Gardener G, Deprest JA. The Impact of Entry Technique and Access Diameter on Prelabour Rupture of Membranes Following Primary Fetoscopic Laser Treatment for Twin-Twin Transfusion Syndrome. Fetal Diagn Ther. 2016;40(2):100-9. doi: 10.1159/000441915. Epub 2016 Apr 14. — View Citation

Quintero RA, Bornick PW, Allen MH, Johson PK. Selective laser photocoagulation of communicating vessels in severe twin-twin transfusion syndrome in women with an anterior placenta. Obstet Gynecol. 2001 Mar;97(3):477-81. doi: 10.1016/s0029-7844(00)01172-8. — View Citation

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Shamshirsaz AA, Chmait RH, Stirnemann J, Habli MA, Johnson A, Hessami K, Mostafaei S, Nassr AA, Donepudi RV, Sanz Cortes M, Espinoza J, Krispin E, Belfort MA. Solomon versus selective fetoscopic laser photocoagulation for twin-twin transfusion syndrome: A systematic review and meta-analysis. Prenat Diagn. 2023 Jan;43(1):72-83. doi: 10.1002/pd.6246. Epub 2022 Oct 11. — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of completed fetoscopic procedures	The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.	3 years from study start date
Primary	Fetal survival at birth	The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.	When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
Secondary	Successful visualization of all targeted vessels	The rate of procedures with these fetoscopes in which there is successful visualization of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.	3 years from study start date
Secondary	Successful coagulation of all targeted vessels	The rate of procedures with these fetoscopes in which there is successful coagulation of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.	3 years from study start date
Secondary	The rate of preterm labor	The rate of preterm labor following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	The rate of preterm premature rupture of membranes (PPROM)	The rate of PPROM following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	The rate of placental abruption	The rate of placental abruption following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	The rate of choriamniotic separation (CAS)	The rate of CAS following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	The rate of iatrogenic septostomy	The rate of iatrogenic septostomy following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	The rate of completed Solomonizations	The rate of completed Solomonizations (if clinically elected to be performed) during a procedure using these fetoscopes will be analyzed.	3 years from study start date
Secondary	The rate of any perioperative complications (within 24 hours post-procedure)	The rate of any perioperative complications following a procedure using these fetoscopes will be analyzed.	24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Secondary	Fetal survival 48 hours post-procedure	The rate of fetal survival at 48 hours following a procedure using these fetoscopes will be analyzed.	24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Secondary	Rate of TAPS	In cases of twin-to-twin transfusion syndrome (TTTS) and selective fetal growth restriction (sFGR), the rate in which twin-anemia-polycythemia (TAPS) was observed following a procedure using these fetoscopes.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Recurrence of TTTS	In cases of twin-to-twin transfusion syndrome (TTTS), the rate in which TTTS recurred following a procedure using these fetoscopes.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Neonatal survival 30 days after birth	The rate of neonatal survival at 30 days of life following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Short term need for ECMO	The rate of ECMO initiation during the first 30 days of life following a procedure using these fetoscopes will be analyzed.	When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Short term morbidity	The rate of short term morbidity during the first 30 days of life following a procedure using these fetoscopes will be analyzed. Short-term morbidity includes neurological problems, gastrointestinal problems, respiratory problems, infections, and other problems associated with prematurity including but not limited to: necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, neonatal sepsis, and neonatal intensive care unit admission.	When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Gestational age at delivery	Gestational age at delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Time from procedure to delivery	Number of days from procedure to delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.	When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Secondary	Length of procedure	The length of time (in minutes) of the procedures using these fetoscopes will be analyzed.	3 years from study start date