An interventional study of Endoscopic Suturing to Create Early Satiety in Morbid Obesity and Weight Loss, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.
The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts.
It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.
The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss.
It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision.
Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.
Device: Endoscopic Suturing to Create Early Satiety
Evaluating the efficacy of endoscopic suturing for weight loss.
Also known as: Endoscopic Cerclage, Bariatric Surgery Revision, Apollo EndoStitch, Apollo OverTube
Mean Weight Loss
We will track patient's weight after their endoscopic bariatric surgery.
Time frame: 3 months after procedure
Number of Participants With Resolved Co-morbidities
We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
Time frame: 2 years
Tolerance
We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.
Time frame: 2 years
| Milestone | All Study Participants |
|---|---|
| Started | 24 |
| Underwent procedure | 23 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
We will track patient's weight after their endoscopic bariatric surgery.
| Pounds | All Study Participants |
|---|---|
| Mean Weight Loss | 13.3 (0 to 40) |
We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
| Participants | All Study Participants |
|---|---|
| Number of Participants With Resolved Co-morbidities | 23 |
We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.
No measurements were reported for this outcome.
Collected over Up to 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Weight Gain | 1/24 (4.2%) | 1/24 (4.2%) | 1/24 (4.2%) |
| Event | Weight Gain |
|---|---|
| LeakGastrointestinal disorders | 1/24 |
| Event | Weight Gain |
|---|---|
| DysphagiaGastrointestinal disorders | 1/24 |
| Age, Continuous(years) | Weight Gain |
|---|---|
| Mean | 47.6 (33 to 61) |
| Sex: Female, Male(Participants) | Weight Gain |
|---|---|
| Female | 22 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Weight Gain |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Weight Gain |
|---|---|
| United States | 24 |
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University of California, San Francisco