CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 303 enrolled
Drug / intervention
REALIZE™ Swedish Adjustable Gastric Banddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00543140
NCT00543140Phase 4Completed
CompareCT.gov

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

Ethicon Endo-Surgery·interventional·Posted Oct 12, 2007·Updated Mar 9, 2016

In Brief

A Phase 4 clinical trial evaluating REALIZE™ Swedish Adjustable Gastric Band for Morbid Obesity. Completed, enrolled 303 participants across 8 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2007
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 18.7 years ago

Interventions

REALIZE™ Swedish Adjustable Gastric Banddevice

Laparoscopic placement of the Swedish Adjustable Gastric Band