Endoscopic Suturing (ES) Registry

Surgery Clinical Trial

Official title:

Prospective Registry for Trans-Orifice Endoscopic Suturing Applications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776188
• Other study ID #: ES Registry 2-682-101
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: American Gastroenterological Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.

To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.

Description:

To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.

To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.

To collect data on the common use endoscopic suturing therapy in other indications.

This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.

This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.

The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.

All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Selected to undergo trans-orifice suturing prior to study enrollment

2. Age 18+ years

3. Patient ASA classification I, II, III, including emergency cases

4. Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment

Exclusion Criteria:

1. Patients who do not meet the clinical criteria for trans-orifice suturing

2. Under age 18 years

3. ASA classification IV

4. Unable to provide informed consent

5. Unable to participate in follow-up assessments

6. Uncorrectable coagulopathy at the time of endoscopic suturing

7. Any terminal disease that limits patient's survival to less than one year

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institution	Baltimore	Maryland
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Borland Grover Clinic	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Arkansas	Little Rock	Arkansas
United States	Northwell Health	Manhasset	New York
United States	Mount Sinai Hospital	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
American Gastroenterological Association	Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dislocation of Stent - distance	Change in the position measured using distance (centimeters).	Change at 2 weeks, 30 days, 3 months
Primary	Dislocation of Stent - location	Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter	Change at 2 weeks, 30 days, 3 months
Primary	Migration Rate of Stent - placement	Distal from placement over time (yes or no)	Change at 2 weeks, 30 days, 3 months
Primary	Migration Rate of Stent - replaced	Stent replaced or re-structured over time (yes or no)	Change at 2 weeks, 30 days, 3 months
Primary	Migration Rate of Stent - sutures	Number of intact Sutures	Change at 2 weeks, 30 days, 3 months
Primary	Migration Rate of Stent - removal	Days to removal and replacement	Change at 2 weeks, 30 days, 3 months
Primary	Excess Weight Loss	Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.	Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
Primary	Total Weight Loss	Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.	Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months