Morbid Obesity Requiring Bariatric SurgeryPhase 4GABYNCT01015469
Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
A Phase 4 study testing Conventional laparoscopic Roux-en-Y gastric bypass and conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring in people with Morbid Obesity Requiring Bariatric Surgery, run by ClinTrio Ltd. at 14 sites in 7 countries.
Trial summary
Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY). The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity Requiring Bariatric Surgery
- What is being tested?
- Conventional laparoscopic Roux-en-Y gastric bypass and conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 14 sitesin 7 countries
- Study dates
- Feb 2009to Mar 2015
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 40 kg /m2 to ≤ 50 kg/m2
- Eating habit: sweet eater and volume eater
- Signed informed consent
- Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet
Who cannot join
- History of obesity surgery
- History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
- Patients not eligible to implement silastic ring size 6.5 cm
- History of drug or alcohol abuse
- History of major psychiatric illness conflicting with patient's compliance
- History of recent or chronic steroid medication
Show all 14Show fewer
- Autoimmune disease
- Inflammatory bowel disease or malabsorptive disease
- Liver cirrhosis (CHILD B + C)
- Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)
- Pregnant women or women with childbearing potential without efficient contraception
- History of cancer in the last five years
- Need of long-term anticoagulant medication for any reason
- Any medication with ingredient ASA
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Germany5 sites, 5 recruiting
- Recruiting
Privatpraxis Chirurgie bei Schlossparkklinik
Berlin, 14059
Volker Lange, Prof.
- Recruiting
Albert-Ludwigs-University
Freiburg im Breisgau, 79106
Konrad W Karcz, MD
- Recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Oliver Mann, MD
- Recruiting
Chirurgische Klinik München-Bogenhausen GmbH
München, 81679
Günther Meyer, MD
- Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, 78011
Norbert Runkel, Prof.
Belgium3 sites, 3 recruiting
- Recruiting
Hospital AZ St.-Jan AV
Bruges, 8000
Bruno Dillemans, MD
- Recruiting
AZ Sint-Blasius
Dendermonde, 9200
Jaques Himpens, MD
- Recruiting
AZ Nikolaas
Sint-Niklaas, 9100
Luc Lemmens, MD
Portugal2 sites, 2 recruiting
- Recruiting
Centro Hospitalar de Lisboa Central
Lisbon, 1150-199
Rui Ribeiro, MD
- Recruiting
Hospital de Sao Sebastiano
Santa Maria de Feira, 4520-211
Mario Nora, MD
Austria1 site
- Active, not recruiting
Hospital Hallein (Scientific Review Board)
Hallein, 5400
Netherlands1 site, 1 recruiting
- Recruiting
Atruim Medical Centre
Heerlen, 6401
Jan W.M. Greve, MD
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lodz
Lodz, 90-152
Tomasz Szewczyk, MD
Saudi Arabia1 site, 1 recruiting
- Recruiting
International Medical Center
Jeddah, 2172
Walid Bukhari, MD
About this study
Official title: International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).
The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.
The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.
Read the detailed description
GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass.
At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years.
Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.
- Being tested
- Conventional laparoscopic Roux-en-Y gastric bypass, conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring
- Keywords
- bariatric, surgery, obesity, Roux-en-Y, gastric, medical device, bypass, adiposity, GaBP-Ring, BMI, banded, laparoscopic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional laparoscopic Roux-en-Y gastric bypassProcedure or surgery
Conventional laparoscopic Roux-en-Y gastric bypass
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ringProcedure or surgery
conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard) Receives: Procedure: Conventional laparoscopic Roux-en-Y gastric bypass |
| Group B | Experimental | Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring Receives: Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
Measured: 0, 3, 6, 12 months and 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid Obesity Requiring Bariatric SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinTrio Ltd.
- Sponsor type
- University, hospital or other
- Investigators
- Konrad W Karcz, MD, Principal investigator, Albert-Ludwigs-University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015469
- Sponsor's protocol ID
- IT5448081
- Other IDs
- EudraCT-No. 2009-016718-26
- Acronym
- GABY
- Status last verified
- Feb 2011
- First submitted
- 17 Nov 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)
- ClinicalTrials.gov ID
- NCT01015469
- Acronym / sponsor ID
- GABY / IT5448081
- Keywords
- bariatric, surgery, obesity, Roux-en-Y, gastric, medical device, bypass, adiposity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- ClinTrio Ltd.University, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 18 Nov 2009 (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.
Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).
The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.
The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.
Detailed description
GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass.
At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years.
Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Conventional laparoscopic Roux-en-Y gastric bypassConventional laparoscopic Roux-en-Y gastric bypass (Golden Standard) |
| Group B | Experimental | Procedure: conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ringConventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 40 kg /m2 to ≤ 50 kg/m2
- Eating habit: sweet eater and volume eater
- Signed informed consent
- Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet
Key exclusion criteria (14 listed)
- History of obesity surgery
- History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
- Patients not eligible to implement silastic ring size 6.5 cm
- History of drug or alcohol abuse
- History of major psychiatric illness conflicting with patient's compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional laparoscopic Roux-en-Y gastric bypassConventional laparoscopic Roux-en-Y gastric bypass | Procedure or surgery | Group A |
| conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ringconventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring) | Procedure or surgery | Group B |
Primary outcome
postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure
Time frame: 0, 3, 6, 12 months and 2, 3, 4, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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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.
Konrad W Karcz, MD principal investigator
Albert-Ludwigs-University of Freiburg
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional laparoscopic Roux-en-Y gastric bypass and conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring in people with Morbid Obesity Requiring Bariatric Surgery, run by ClinTrio Ltd. at 14 sites in 7 countries.
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 4 inclusion and 14 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 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Belgium, Portugal, Austria, Netherlands and 2 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Burkhart Frankenberger (+49-511-38814-0, info@clintrio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure (time frame: 0, 3, 6, 12 months and 2, 3, 4, 5 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 17 Feb 2011.