ObesityNCT01752829
Post-marketing Surveillance Study of A.M.I. Protector Adjustable Gastric Band
An observational study of Obesity, run by Weight to Go Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jan 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese subjects who are candidates for gastric banding
Who may be able to join
- obese subjects with BMI >30kg/m2 with one or more co-morbidities
- Obese subjects with BMI >40kg/m2 with or without co-morbidities
Who cannot join
- previous history of drug abuse
- history of bleeding disorders
- On long-term steroid therapy
- Pregnancy
- Previous gastric surgery
- Chronic lung disease
Show all 11Show fewer
- history of psychotic disease
- Inflammatory bowel disease
- Unstable angina or dysrhythmia
- liver cirrhosis
- Autoimmune disease (SLE etc)
Trial locations and contacts
1 site in 1 country.
Dr David Ashton, MD PhD contact
United Kingdom1 site
Weight To Go Ltd
Birmingham, B15 3ES
Dr David Ashton, MD PhD, 07899913963, wdashton@compuserve.com
Chrissie Twigg, MA, MBA, 07867506195, chrissietwigg@healthierweight.com
About this study
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.
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, gastric, banding, Weight, co-morbidities, dilatation, Excess weight loss, adjustable gastric banding
- Medical subject headings
- Obesity, Body Weight, Dilatation, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage excess weight loss (%EWL)
Measured: 3 years
Secondary outcomes (2)
Impact of weight loss on co-morbidities such as type 2 diabetes, hypertension etc
Measured: 3-years
Incidence of band-related complications such as band slippage; erosion; port/tubing complications; port/band infection; pouch dilatation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Weight to Go Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr David Ashton, MD PhD, Principal investigator, Weight to Go Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752829
- Sponsor's protocol ID
- Version PBS.V2.11.12
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01752829
- Acronym / sponsor ID
- Version PBS.V2.11.12
- Conditions
- Obesity
- Keywords
- Obesity, gastric, banding, Weight, co-morbidities, dilatation, Excess weight loss, adjustable gastric banding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weight to Go LtdUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese subjects who are candidates for gastric banding
Key inclusion criteria (2 listed)
- obese subjects with BMI >30kg/m2 with one or more co-morbidities
- Obese subjects with BMI >40kg/m2 with or without co-morbidities
Key exclusion criteria (11 listed)
- previous history of drug abuse
- history of bleeding disorders
- On long-term steroid therapy
- Pregnancy
- Previous gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage excess weight loss (%EWL)
Time frame: 3 years
2 secondary outcomes
Impact of weight loss on co-morbidities such as type 2 diabetes, hypertension etc
Time frame: 3-years
Incidence of band-related complications such as band slippage; erosion; port/tubing complications; port/band infection; pouch dilatation
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr David Ashton, MD PhD contact
Dr David Ashton, MD PhD principal investigator
Weight to Go Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Weight to Go Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr David Ashton, MD PhD (07899913963), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage excess weight loss (%EWL) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012.