Clinical trial NCT03776188: Endoscopic Suturing (ES) Registry
Official title: Prospective Registry for Trans-Orifice Endoscopic Suturing Applications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Endoscopic Suturing
Bariatric Revision
Stent Fixation
Bariatric Surgery
Lead sponsor: American Gastroenterological Association
Sponsor class: OTHER
Collaborators: name: Apollo Endosurgery, Inc.
First posted: 2018-12-14
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a condition that can be treated with trans-orifice endoscopic surgery.

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.

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

Primary outcomes:
measure: Dislocation of Stent - distance
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Dislocation of Stent - location
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Migration Rate of Stent - placement
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Migration Rate of Stent - replaced
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Migration Rate of Stent - sutures
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Migration Rate of Stent - removal
timeFrame: Change at 2 weeks, 30 days, 3 months
measure: Excess Weight Loss
timeFrame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
measure: Total Weight Loss
timeFrame: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Borland Grover Clinic
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Penn State Milton S. Hershey School of Medicine
name: Jennifer Maranki, MD
role: PRINCIPAL_INVESTIGATOR
References: