Morbid ObesityNCT01077193
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
A study testing Gastric Plication in people with Morbid Obesity, run by Ethicon Endo-Surgery at 3 sites in 2 countries.
Trial summary
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric Plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2009to May 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing to give consent and comply with evaluation and treatment schedule (for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial);
- 18 to 65 years of age (inclusive);
- Subject meets ASMBS and NIH criteria: (consensus.nih.gov)
- BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:
- Hyperlipidemia
- Mild obstructive sleep apnea (per Investigator discretion)
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- Hypertension
- Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated;
- ASA Class I - III;
- Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
- HbA1C < 11%; and
- For subjects who have Type 2 diabetes, medication regimen is no more complex (2 oral medications) than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
Who cannot join
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;
- Participation in any other investigational device or drug study (non-survey based trial; long-term enrollment in such studies as requiring periodic laboratory tests, etc., would be allowed) 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;
- 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 greater than 2cm in length, with the exception of a small sliding hiatal hernia previously undiagnosed and discovered during the surgical procedure;
- Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
- Known history of clotting disorders, hemoglobinopathies, and hemolytic disorders, including pulmonary embolus and Deep Vein Thrombosis;
- Pancreatitis;
- Gallstones (confirmed via ultrasound);
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Use of thiazolidinediones ("glitazones"), or
- 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; and
- 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
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
- Conditions
- Morbid Obesity
- Being tested
- Gastric Plication
- Keywords
- Bariatric, Obesity
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric PlicationProcedure or surgery
A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Plication Surgery | Other | Not described Receives: Procedure: Gastric Plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward
Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL
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 posted1 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Study was terminated due to commercial considerations and potential patient attrition at 3 years. There were no patient safety or procedure efficacy reasons.
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 Morbid 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
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077193
- Sponsor's protocol ID
- CI-09-0006
- Status last verified
- Jan 2014
- First submitted
- 25 Feb 2010
- Last updated
- 7 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
- ClinicalTrials.gov ID
- NCT01077193
- Acronym / sponsor ID
- CI-09-0006
- Conditions
- Morbid Obesity
- Keywords
- Bariatric, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to commercial considerations and potential patient attrition at 3 years. There were no patient safety or procedure efficacy reasons.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Posted 13 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Plication Surgery | Other | Procedure: Gastric Plication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is willing to give consent and comply with evaluation and treatment schedule (for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial);
- 18 to 65 years of age (inclusive);
- Subject meets ASMBS and NIH criteria: (consensus.nih.gov)
- BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:
- ASA Class I - III;
Key exclusion criteria (26 listed)
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;
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 |
|---|---|---|
| Gastric PlicationA laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure. | Procedure or surgery | Gastric Plication Surgery |
Primary outcome
Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward
Time frame: 3 years
Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Plication in people with Morbid Obesity, run by Ethicon Endo-Surgery at 3 sites in 2 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 12 inclusion and 26 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: stopped early, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Czechia. 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 13 Sep 2013). 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?
Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward (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 7 Feb 2014.