The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of the gastric pylorus to delay gastric emptying and treat obesity.
The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis and rationale for the study is that gastric pyloric restriction will cause early and prolonged satiety which will lead to decreased food intake and eventual weight loss. Both safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model. Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes general history and physical examination, biochemical and laboratory analysis and informed consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline visit involves a four hour gastric emptying scan in order to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach. The baseline visit also includes nutritional counselling. The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be prepped following usual practices and placed in a left lateral decubitus position. Following induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic evaluation of the esophagus, stomach and jejunum following standard medical practices will be performed. The endoscope with mounted suturing device is advanced through an over-tube to the antrum and assess target area for stitch placement (physician will select appropriate target site in relation to participant's anatomy). The number of sutures required will vary for each procedure based on the size of the pylorus; however, it is thought that one or two sutures across the pylorus will be sufficient enough to achieve a functional restriction of the pylorus. Participants will to be observed for a minimum of 1 hour following the procedure to monitor for adverse events. Patients will be recommended to take the following medications in order to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting. All participants will be required to adhere to the follow-up schedule outlined below unless they have withdrawn their consent or died. The reason(s) the participant is not followed will be documented by the investigator. Follow-up for all participants will include a telephone contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months after the procedure participants will undergo repeat endoscopy to access the stomach and the suture site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract. However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested.
North Shore University Hospital
Manhasset, New York, United States
Percent weight loss
The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: \[(Baseline Weight - Final 6 month Weight)/Baseline Weight\] x 100%.
Time frame: At 1, 3 and 6 months
Participant satisfaction
Participant satisfaction with clinical outcomes at 6 months post-procedure will be captured on an ordinal scale of 1 to 5 with 1 representing very satisfied and 5 representing not satisfied at all. The response will be tabulated and presented using descriptive statistics.
Time frame: At 6 months post procedure
Delay in gastric emptying
A gastric emptying scan will be done prior to the endoscopic suturing procedure and four weeks after the endoscopic procedure to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach.
Time frame: From baseline to 4 weeks post procedure
Change in BMI
BMI at 1, 3 and 6 months will be tabulated and summarized using descriptive statistics.
Time frame: At 1, 3 and 6 Months
Percentage of Responders
Percentage of participants losing at least 5%, 10%, 15% and 20% of weight at 1, 3 and 6 months will be tabulated and reported.
Time frame: At 1, 3 and 6 Months
Change in Medication Use.
If the participant is taking any medications for Obesity related complications such as Hypertension and Diabetes, then the dosage of those medications at 1, 3 and 6 months will be recorded and trends will be noted as either remained the same, decreased or increased.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At 1, 3 and 6 Months