ObesityNCT00721227
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
A study testing Reduction Gastroplasty in people with Obesity, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Reduction Gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
- Subject is willing to give consent and comply with evaluation and treatment schedule;
- 21 to 60 years of age (inclusive);
- BMI > 35 kg/m2 and < 50 kg/m2 (BMI 35-40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);
- Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
- Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, per site standard of care (SOC); and
- Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.
Who cannot join
- Subjects will be excluded from the study for any of the following:
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure;
- Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
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- Any condition which precludes compliance with the study, including:
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
- Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
- Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
- Uncontrolled hypertension;
- Portal hypertension;
- Treatment with insulin (more than 50 units a day);
- Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
- Cirrhosis;
- Congenital or acquired intestinal telangiectasia;
- Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
- Presence of hiatal hernia;
- Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
- Pancreatitis;
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
- History or presence of pre-existing autoimmune connective tissue disease;
- Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
Read the detailed description
The overall plan for all subjects consists of the following elements:
- Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
- Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
- Subjects are followed for 12 months to evaluate outcomes and potential complications.
- Conditions
- Obesity
- Being tested
- Reduction Gastroplasty
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction GastroplastyProcedure or surgery
- Subjects will undergo reduction gastroplasty by gastric plication
- Subjects are followed for 12 months to evaluate outcomes and potential complications.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Curve | Active comparator | Reduction Gastroplasty by Gastric Plication on Anterior Curve Receives: Procedure: Reduction Gastroplasty |
| Greater Curve | Active comparator | Reduction Gastroplasty by Gastric Plication on Greater Curve Receives: Procedure: Reduction Gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Gastric Plication Using Reduction Gastroplasty
The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Measured: Immediately post-operative
Secondary outcomes (2)
Durability of Gastric Plications Following Reduction Gastroplasty
The number of participants who completed month 12 gastroscopies showing intact plications.
Measured: 12 month
Weight Loss Following Reduction Gastroplasty
Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip R Schauer, M.D, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721227
- Sponsor's protocol ID
- CI-07-0005
- Status last verified
- Sep 2010
- First submitted
- 9 Jul 2008
- Last updated
- 8 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
- ClinicalTrials.gov ID
- NCT00721227
- Acronym / sponsor ID
- CI-07-0005
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Posted 18 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
Detailed description
The overall plan for all subjects consists of the following elements:
- Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
- Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
- Subjects are followed for 12 months to evaluate outcomes and potential complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Curve | Active comparator | Procedure: Reduction GastroplastyReduction Gastroplasty by Gastric Plication on Anterior Curve |
| Greater Curve | Active comparator | Procedure: Reduction GastroplastyReduction Gastroplasty by Gastric Plication on Greater Curve |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
- Subject is willing to give consent and comply with evaluation and treatment schedule;
- 21 to 60 years of age (inclusive);
- BMI > 35 kg/m2 and < 50 kg/m2 (BMI 35-40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);
- Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);
Key exclusion criteria (24 listed)
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure;
- Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;
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 |
|---|---|---|
| Reduction Gastroplasty* Subjects will undergo reduction gastroplasty by gastric plication * Subjects are followed for 12 months to evaluate outcomes and potential complications. | Procedure or surgery | Anterior Curve, Greater Curve |
Primary outcome
Successful Gastric Plication Using Reduction Gastroplasty
Time frame: Immediately post-operative
The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
2 secondary outcomes
Durability of Gastric Plications Following Reduction Gastroplasty
Time frame: 12 month
Weight Loss Following Reduction Gastroplasty
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip R Schauer, M.D principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction Gastroplasty in people with Obesity, run by Ethicon Endo-Surgery at 1 site in United States.
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 7 inclusion and 24 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: finished, as of the sponsor's last update on 8 Sep 2010. 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 States. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Gastric Plication Using Reduction Gastroplasty (time frame: Immediately post-operative). 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 8 Sep 2010.