ULTIMATE Study for Weight Loss
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating Impact of ULTIMATE Number of G-CATH EZ- Suture Anchors Placed Endoscopically on Motility, Metabolism, Satiety, and Weight Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity|
- Weight Loss [ Time Frame: 18 months ] [ Designated as safety issue: No ]Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint
- Gastric emptying [ Time Frame: Immediately Pre-procedure, & 2 & 6 months post procedure ] [ Designated as safety issue: No ]This test consists of determining if there is a Clinically significant change in the duration of a radioactive marker (which is non-absorbable, and free of any food components) in a stomach pre and post POSE. In order to carry out this test, a piece of food is marked with a radioactive isotope and, by using an abdominal gamma camera; detections of radioactivity are made in the stomach during the postprandial period.
- Satiety [ Time Frame: Immediately Pre-procedure, & 2 & 6 months post procedure ] [ Designated as safety issue: No ]This test consists of determining if there is a Clinically significant change in Satiety pre and post POSE. The subjects ingest a nutritional drink (Ensure) at a constant rate of 30 mL per minute, constantly filling the glass with a perfusion pump (Gemini PC-2, IMED, San Diego, CA). (The subjects are not conscious of the volume being ingested.) The subjects are instructed to maintain consumption at the fill rate. Participants take note of their sensation of satiety with a graphical classification scale, which combines verbal descriptors on a scale of 0 to 5 (0 = no symptoms, 1 = first sensation of fullness [threshold]; 2 = light, 3 = moderate, 4 = severe, and 5 = maximum fullness or unbearable). The participants are told to stop taking the food product when a score of 5 is obtained. The maximum consumption of volume of the nutritional drink is recorded.
- Peptide Measurements [ Time Frame: Immediately Pre-procedure & 2 Months post procedure ] [ Designated as safety issue: No ]
This test consists of determining if there is a Clinically significant change in peptides pre and post procedure.
- Samples to be collected when fasting and 30, 60, 90, and 120 minutes after a standard meal (A meal consisting of 400 calories is used), The meal must be consumed within 10 minutes.
- Samples to be collected by ELISA are: C-peptide, serum insulin, glucose, PYY, GLP-1 (active), leptin, and GIP. Total ghrelin level to be analyzed by RIA.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Ultimate Anchor
Use of the g-Cath Suture Anchor Delivery Catheter and accessories in placing the ultimate number of anchors for weight loss.
Device: g-Cath Suture Anchor Delivery Catheter
Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors.
This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.