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

December 18, 2012 updated by: Weight to Go Ltd

A Single-arm, Observational, Post-marketing Study to Evaluate the Effects of the A.M.I. Protector Adjustable Gastric Band on Weight Loss, Co-morbidities, Adverse Events and Other Clinical Characteristics.

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Where patients express an interest in the A.M.I. Protector Band, they will be given a Patient Information Sheet which will form the basis of a discussion with the attending physician. Patients opting for the Protector Band will be told that their anonymised clinical data will be stored in a secure database and used for research purposes. They will also be required to attend for regular follow-up (see below) for a period of three years after implantation.

Following this initial consultation, a minimum period of 2-weeks will be required before the patient is listed for surgery. This will provide a suitable period during which the patient can consider the options and seek clarification on any points about which they are unclear.

In the case of the A.M.I. Protector Band the surgery will be performed in two locations:

  • Spire Hospital Parkway (Birmingham)
  • Spire Hospital Manchester

All band procedures will be performed by one of two surgeons; Mr. Paul Super and Prof. Franco Favretti according to a standard protocol.

In all cases, informed consent will be obtained prior to surgery.

Patients will remain in hospital overnight and be discharged the following day.

On discharge, patients will be given comprehensive written instructions regarding optimal nutritional and physical activity. They will also be provided with a 24-hour, Emergency Helpline number in the event of problems.

All patients will be followed for a period of three years, with a formal review at 5 weeks and then at 3, 6, 9, 12, 18, 24 and 36 months. However, patients will be free to attend additional clinics between the formal reviews should they wish. At each visit the patient's weight, height, waist/hip ratio and blood pressure (BP) will be recorded. In addition, a range of blood tests will be carried out at baseline, at 12, 24 and 36 months. A self-administered Quality of Life questionnaire will be completed prior to surgery and then at 12, 24 and 36 months of follow-up.

At the completion of the 3-year study, patients will be able to transition into our usual care gastric band programme for long-term follow-up.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese subjects who are candidates for gastric banding

Description

Inclusion Criteria:

  • obese subjects with BMI >30kg/m2 with one or more co-morbidities
  • Obese subjects with BMI >40kg/m2 with or without co-morbidities

Exclusion Criteria:

  • previous history of drug abuse
  • history of bleeding disorders
  • On long-term steroid therapy
  • Pregnancy
  • Previous gastric surgery
  • Chronic lung disease
  • history of psychotic disease
  • Inflammatory bowel disease
  • Unstable angina or dysrhythmia
  • liver cirrhosis
  • Autoimmune disease (SLE etc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage excess weight loss (%EWL)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of weight loss on co-morbidities such as type 2 diabetes, hypertension etc
Time Frame: 3-years
3-years
Incidence of band-related complications such as band slippage; erosion; port/tubing complications; port/band infection; pouch dilatation
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weight to Go Ltd

Investigators

  • Principal Investigator: Dr David Ashton, MD PhD, Weight To Go Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version PBS.V2.11.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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