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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Weight to Go Ltd
Sponsor:
Information provided by (Responsible Party):
Weight to Go Ltd
ClinicalTrials.gov Identifier:
NCT01752829
First received: December 11, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
Obesity

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Weight to Go Ltd:

Primary Outcome Measures:
  • Percentage excess weight loss (%EWL) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of weight loss on co-morbidities such as type 2 diabetes, hypertension etc [ Time Frame: 3-years ] [ Designated as safety issue: No ]
  • Incidence of band-related complications such as band slippage; erosion; port/tubing complications; port/band infection; pouch dilatation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obese subjects who are candidates for gastric banding

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752829

Contacts
Contact: Dr David Ashton, MD PhD 07899913963

Locations
United Kingdom
Weight To Go Ltd Not yet recruiting
Birmingham, United Kingdom, B15 3ES
Contact: Dr David Ashton, MD PhD    07899913963    wdashton@compuserve.com   
Contact: Chrissie Twigg, MA, MBA    07867506195    chrissietwigg@healthierweight.com   
Principal Investigator: Dr David Ashton, MD, PhD         
Sponsors and Collaborators
Weight to Go Ltd
Investigators
Principal Investigator: Dr David Ashton, MD PhD Weight to Go Ltd
  More Information

No publications provided

Responsible Party: Weight to Go Ltd
ClinicalTrials.gov Identifier: NCT01752829     History of Changes
Other Study ID Numbers: Version PBS.V2.11.12
Study First Received: December 11, 2012
Last Updated: December 18, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Weight to Go Ltd:
Obesity
gastric
banding
Weight
co-morbidities
dilatation
Excess weight loss
adjustable gastric banding

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014