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Post-marketing Surveillance Study of A.M.I. Protector Adjustable Gastric Band

NCT01752829 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2012-12-19

No results posted yet for this study

Summary

The laparoscopic adjustable gastric band (LAGB) is a safe and effective surgical intervention for chronically obese patients who have exhausted all non-surgical weight loss treatments. Numerous published studies have confirmed both the safety and efficacy of the LAGB and its beneficial impact on obesity-associated conditions, such as type 2 diabetes, joint and back pain and hypertension. The A.M.I. Protector Band is a modification of an existing gastric band (the A.M.I. Soft Gastric Band) which has been in use since 2001 and which has been shown to be both safe and effective. The specific design modification is in the form of a section of mesh, which provides support to the gastric pouch and which further restricts food portion sizes. The expectation is that this will deliver optimal weight loss whilst having the maximum possible impact on obesity-associated conditions such as type 2 diabetes and hypertension. In the longer term, there is also the possibility that the Protector Band will reduce the incidence of band complications such as slippage and dilatation (or stretching) of the gastric pouch. In this study we will recruit approximately 200 patients who will then undergo surgical implantation of the A.M.I. Protector Band. The study participants will then be followed for a period of 3-years, during which time we will record weight loss, changes in co-morbid conditions such as diabetes and the incidence of band complications, including slippage and pouch dilatation.

Conditions

Sponsors & Collaborators

  • Weight to Go Ltd

    lead OTHER

Principal Investigators

  • Dr David Ashton, MD PhD · Weight to Go Ltd

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01752829 on ClinicalTrials.gov