Endoscopic Suturing (ES) Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Registry for Trans-Orifice Endoscopic Suturing Applications

Conditions
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Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Selected to undergo trans-orifice suturing prior to study enrollment Age 18+ years Patient ASA classification I, II, III, including emergency cases Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment Exclusion Criteria: Patients who do not meet the clinical criteria for trans-orifice suturing Under age 18 years ASA classification IV Unable to provide informed consent Unable to participate in follow-up assessments Uncorrectable coagulopathy at the time of endoscopic suturing Any terminal disease that limits patient's survival to less than one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no groups - observational study<br>no groups - observational study | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Suturing, Bariatric Revision, Stent Fixation, Bariatric Surgery