Surgery
Conditions
Keywords
Endoscopic Suturing, Bariatric Revision, Stent Fixation, Bariatric 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.
Interventions
None listed
Sponsors
Apollo Endosurgery, Inc.
American Gastroenterological Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dislocation of Stent - distance | Change at 2 weeks, 30 days, 3 months | Change in the position measured using distance (centimeters). |
| Dislocation of Stent - location | Change at 2 weeks, 30 days, 3 months | Change in the position measured using location. Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter |
| Migration Rate of Stent - placement | Change at 2 weeks, 30 days, 3 months | Distal from placement over time (yes or no) |
| Migration Rate of Stent - replaced | Change at 2 weeks, 30 days, 3 months | Stent replaced or re-structured over time (yes or no) |
| Migration Rate of Stent - sutures | Change at 2 weeks, 30 days, 3 months | Number of intact Sutures |
| Migration Rate of Stent - removal | Change at 2 weeks, 30 days, 3 months | Days to removal and replacement |
| Excess Weight Loss | Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months | 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. |
| Total Weight Loss | Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months | 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. |
Countries
United States
Outcome results
None listed