Endoscopic Suturing (ES) Registry

Prospective Registry for Trans-Orifice Endoscopic Suturing Applications

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.

Study Overview

• Status: Completed
• Conditions: Surgery

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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • University of Arkansas
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Jacksonville, Florida, United States, 32256
      • Borland Grover Clinic
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Medical Institution
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75214
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with a condition that can be treated with trans-orifice endoscopic surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
no groups - observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation of Stent - distance	Change in the position measured using distance (centimeters).	Change at 2 weeks, 30 days, 3 months
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
Migration Rate of Stent - placement	Distal from placement over time (yes or no)	Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - replaced	Stent replaced or re-structured over time (yes or no)	Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - sutures	Number of intact Sutures	Change at 2 weeks, 30 days, 3 months
Migration Rate of Stent - removal	Days to removal and replacement	Change at 2 weeks, 30 days, 3 months
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
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

Collaborators and Investigators

• Sponsor: American Gastroenterological Association
• Collaborators: Apollo Endosurgery, Inc.
• Investigators: Principal Investigator: Jennifer Maranki, MD, Penn State Milton S. Hershey School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Endoscopic Suturing; Bariatric Revision; Stent Fixation
• Other Study ID Numbers: ES Registry 2-682-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No