Morbid Obesity Clinical Trial
Official title:
A Post Implantation/Post Market Evaluation of Safety and Quality of Life in Subjects Implanted With the Swedish Adjustable Gastric Band (SAGB) During Protocol CI-02-0006
The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.
NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205 (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required additional subjects with long-term safety data. These subjects enrolled under protocol CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original intent was to pool the data together from the above two studies to obtain the appropriate sample size for estimation of the re-operation rate at 4 and 5 years post implantation. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03657927 -
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
|
N/A | |
| Recruiting |
NCT04934826 -
Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass
|
N/A | |
| Completed |
NCT03181347 -
The Microbiology of Bariatric Surgery
|
N/A | |
| Completed |
NCT03886870 -
Obesity, Lifestyle and Work Intervention
|
N/A | |
| Active, not recruiting |
NCT04433338 -
The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
|
N/A | |
| Completed |
NCT03553849 -
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
|
N/A | |
| Completed |
NCT05854875 -
Diabetes Remission After RYGBP and RYGBP With Fundus Resection
|
N/A | |
| Not yet recruiting |
NCT03203161 -
Registry on Obesity Surgery in Adolescents
|
||
| Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
| Recruiting |
NCT02129296 -
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01564732 -
Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding
|
N/A | |
| Completed |
NCT02033265 -
Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
|
||
| Completed |
NCT01963637 -
Gastric Volumetry by Gastric Tomodensitometry With Gas
|
N/A | |
| Not yet recruiting |
NCT01652105 -
Randomized Trial of Preoperative Diets Before Bariatric Surgery
|
N/A | |
| Terminated |
NCT01759550 -
Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
|
||
| Completed |
NCT01955993 -
Fentanyl Metabolism in Obese Adolescents
|
N/A | |
| Completed |
NCT01149512 -
Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program
|
N/A | |
| Recruiting |
NCT01685177 -
Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient
|
N/A | |
| Completed |
NCT01675713 -
Lifestyleintervention for the Treatment of Severe Obesity
|
N/A | |
| Completed |
NCT02414893 -
Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients
|
N/A |