Morbid Obesity
Conditions
Keywords
Bariatric, Obesity
Brief 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.
Interventions
PROCEDUREGastric Plication
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.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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); 2. 18 to 65 years of age (inclusive); 3. 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) * Hypertension * Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated; 4. ASA Class I - III; 5. 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; 6. HbA1C \< 11%; and 7. 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.
Exclusion criteria
1. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit; 2. Previous malabsorptive or restrictive procedures performed for the treatment of obesity; 3. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy; 4. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery; 5. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring \> 2 medications, or history of suicide attempts; 6. 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; 7. 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. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices); 7. Cirrhosis; 8. Congenital or acquired intestinal telangiectasia; 9. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus; 10. 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; 11. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery; 12. Known history of clotting disorders, hemoglobinopathies, and hemolytic disorders, including pulmonary embolus and Deep Vein Thrombosis; 13. Pancreatitis; 14. Gallstones (confirmed via ultrasound); 15. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders; 16. Use of thiazolidinediones (glitazones), or 17. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study; 8. History or presence of pre-existing autoimmune connective tissue disease; and 9. 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 |
|---|---|---|
| Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward | 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 |
Countries
Czechia, United States
Participant flow
Recruitment details
The enrollment period began in October 2009 and ended in November 2010 at three sites (1 academic site, 2 medical clinics).
Pre-assignment details
No significant events were involved - subjects were evaluated for inclusion and exclusion criteria and proceeded to surgery if they qualified. This is a 1-arm trial.
Participants by arm
| Arm | Count |
|---|---|
| Gastric Plication Surgery Gastric Plication : 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. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study Terminated by Sponsor | 40 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Gastric Plication Surgery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 43.4 years STANDARD_DEVIATION 10.43 |
| Region of Enrollment Czech Republic | 15 participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 44 |
| serious Total, serious adverse events | 8 / 44 |
Outcome results
Primary
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
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastric Plication Surgery | Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward | 37.9 percentage of baseline excess weight | Standard Deviation 25.18 |
Comparison: A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.p-value: 0.322795% CI: [30.2, 45.5]t-test, 1 sided