PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

Intrauterine Adhesion Clinical Trial

— PREG1  

Official title:

PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381728
• Other study ID #: PREG1
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: November 2021
• Source: Womed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility. Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days. The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

Description:

Intrauterine adhesions (IUA) are defined as "fibrous strings at opposing walls of the uterus and/or cervix leading to partial or complete obliteration of the cavity". IUAs are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complications and infertility. Womed Leaf™ is a sterile, degradable polymer film specifically design for intrauterine use. It is inserter in the uterus like an intrauterine device. Once released it will self-deploy into the uterine cavity to form a mechanical barrier keeping uterus walls separated during healing, for several days, thus preventing the formation or recurrence of intrauterine adhesions. It is degraded and discharged naturally through the cervix and vagina in less than 30 days. The PREG1 clinical investigation is a prospective multicenter, single arm study, designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy in preventing IUA at second look hysteroscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women = 40 years AND no childbearing wish, OR history of permanent sterilization;
• Subject scheduled for hysteroscopic myomectomy for one or more myoma(s) where one myoma is at least 10 mm in size (=10mm) as estimated by pre-operative ultrasound measurement of the largest diameter,
• Hysterometry prior to device insertion = 6cm and = 9cm.
• Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee prior to participating in this clinical investigation.
• Subjects who can comply with the study follow-up or other study requirements Exclusion Criteria:

Pre-operative exclusion criteria:

• Current pregnancy
• Abnormal uterine cavity according to ESHRE classification I to VI, such as unicornis, bicornis, septate, duplex
• Known or suspected endometrial hyperplasia
• Medical history of cervical or endometrial cancer
• Active pelvic infection or medical history of pelvic peritonitis
• Intrauterine device in situ
• Known contraindication or hypersensitivity to PEO or PLA, and to medications such as aspirin….
• Concurrent medical condition with a life expectancy of less than 12 months
• Full endometrial ablation

Per-operative exclusion criteria:

• Adenomyosis
• Inflammation (endometritis)
• Abnormal uterine cavity
• Hysterometry < 6cm or >9cm
• Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• Womed Leaf
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
France	CHU Nîmes	Nîmes
France	CHU Bicêtre (APHP)	Paris
Netherlands	Bergman Clinics	Amsterdam
Netherlands	Zaans Medical Center	Amsterdam
Netherlands	Isala Zwolle	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Womed

Countries where clinical trial is conducted

Belgium,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse Events)	The number and severity of polymer film related adverse event	30 days
Primary	Efficacy (Rate of Patient With no IUA)	Freedom from intrauterine adhesion	At second look hysteroscopy between 4 and 8 weeks
Primary	Efficacy (Intrauterine Adhesion Severity According to AFS Classification)	Severity of IUAs according to American Fertility Society (AFS) classification systems of adhesions.; Pronostic classification => Hysteroscopy score Stade I (mild) => 1-4 Stade II (moderate) => 5-8 Stade III (severe) => 9-12	At second look hysteroscopy between 4 and 8 weeks
Primary	Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)	Severity of IUAs according to European Society of Gynecological Endoscopy (ESGE) classification systems of adhesions.; I => Thin or filmy IUA easily ruptured by HSC sheath alone. Cornual areas normal II => Singular dense IUA connecting separate parts of the uterine cavity. Visualization of both tubal ostia possible. Cannot be ruptured by HSC sheath alone IIa => Occluding IUA only in the region of the internal cervical os. Upper uterine cavity normal III => Multiple dense IUA connecting separate parts of the uterine cavity. Unilateral obliteration of ostial areas of the tubes IV => Extensive dense IUA with (partial) occlusion of the uterine cavity. Both tubal ostial areas (partially) occluded Va => Extensive endometrial scarring and fibrosis in combination with grade I or grade II IUA with amenorrhea or pronounced hypomenorrhea Vb => Extensive endometrial scarring and fibrosis in combination with grade III or grade IV IUA with amenorrhea	At second look hysteroscopy between 4 and 8 weeks
Secondary	Adverse Events	Number of adverse events (AE) at 30 days	30 days
Secondary	Device Technical Success	Defined as the rate of success of the following 2 steps : insertion and release	During operation: T=0
Secondary	Womed Leaf Residuals	Presence of Womed Leaf residuals in the uterus	At second look hysteroscopy: 4-8 weeks
Secondary	Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge	Uterine film discharge experience as recalled by subject using a survey to be asked to the patient	At second look hysteroscopy: 4-8 weeks
Secondary	Device Manipulation	Device manipulation duration from insertion to withdrawal.	During intervention: T=0
Secondary	Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))	Uterine film discharge experience as recalled by subject using a survey to be asked to the patient	At second look hysteroscopy: 4-8 weeks