Obesity
Conditions
Brief summary
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.
Interventions
PROCEDUREReduction Gastroplasty
* Subjects will undergo reduction gastroplasty by gastric plication * Subjects are followed for 12 months to evaluate outcomes and potential complications.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Subjects are considered appropriate candidates for the study if they fulfill the following criteria: 1. Subject is willing to give consent and comply with evaluation and treatment schedule; 2. 21 to 60 years of age (inclusive); 3. 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); 4. Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria); 5. 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 6. 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.
Exclusion criteria
Subjects will be excluded from the study for any of the following: 1. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery; 2. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit; 3. Previous mal-absorptive or restrictive procedures performed for the treatment of obesity; 4. Scheduled concurrent surgical procedure; 5. Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment; 6. Any condition which precludes compliance with the study, including: 1. 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; 2. Congenital or acquired anomalies of the GI tract, including atresias or stenosis; 3. Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate; 4. Uncontrolled hypertension; 5. Portal hypertension; 6. Treatment with insulin (more than 50 units a day); 7. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices); 8. Cirrhosis; 9. Congenital or acquired intestinal telangiectasia; 10. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus; 11. Presence of hiatal hernia; 12. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery; 13. Pancreatitis; 14. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders; 15. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study; 7. History or presence of pre-existing autoimmune connective tissue disease; 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Gastric Plication Using Reduction Gastroplasty | Immediately post-operative | The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of Gastric Plications Following Reduction Gastroplasty | 12 month | The number of participants who completed month 12 gastroscopies showing intact plications. |
| Weight Loss Following Reduction Gastroplasty | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.
Participants by arm
| Arm | Count |
|---|---|
| Anterior Curve Reduction Gastroplasty by Gastric Plication on Anterior Curve | 9 |
| Greater Curve Reduction Gastroplasty by Gastric Plication on Greater Curve | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Noncompliance with scheduled visits. | 1 | 0 |
Baseline characteristics
| Characteristic | Greater Curve | Anterior Curve | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 9 Participants | 15 Participants |
| Age Continuous | 36.8 years STANDARD_DEVIATION 8.42 | 45.0 years STANDARD_DEVIATION 10.37 | 41.7 years STANDARD_DEVIATION 10.19 |
| Region of Enrollment United States | 6 participants | 9 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 6 / 6 |
| serious Total, serious adverse events | 0 / 9 | 2 / 6 |
Outcome results
Primary
Successful Gastric Plication Using Reduction Gastroplasty
The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Time frame: Immediately post-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Curve | Successful Gastric Plication Using Reduction Gastroplasty | 9 participants |
| Greater Curve | Successful Gastric Plication Using Reduction Gastroplasty | 6 participants |
Secondary
Durability of Gastric Plications Following Reduction Gastroplasty
The number of participants who completed month 12 gastroscopies showing intact plications.
Time frame: 12 month
Population: Includes only participants who completed month 12 gastroscopy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Curve | Durability of Gastric Plications Following Reduction Gastroplasty | 4 participants |
| Greater Curve | Durability of Gastric Plications Following Reduction Gastroplasty | 5 participants |
Secondary
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.
Time frame: 12 months
Population: Includes only participants who completed month 12 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior Curve | Weight Loss Following Reduction Gastroplasty | 23.30 Percentage of weight loss | Standard Deviation 24.88 |
| Greater Curve | Weight Loss Following Reduction Gastroplasty | 53.43 Percentage of weight loss | Standard Deviation 22.67 |