Endoscopic Suturing (ES) Registry

NCT ID: NCT03776188

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2021-11-30

Brief 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.

Detailed 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.

Conditions

Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

no groups - observational study

no groups - observational study

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apollo Endosurgery, Inc.

INDUSTRY

Sponsor Role: collaborator

American Gastroenterological Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Maranki, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Milton S. Hershey School of Medicine

Locations

University of Arkansas

Little Rock, Arkansas, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Borland Grover Clinic

Jacksonville, Florida, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

Northwell Health

Manhasset, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

ES Registry 2-682-101

Identifier Type: -

Identifier Source: org_study_id