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This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | POSE2.0 Treatment with Lifestyle Modification |
|
| Control | No Intervention | Lifestyle Modification alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors | Device | POSE2.0 (g-Cath EZ snowshoe suture anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total body weight loss (%TBWL) following randomization | To be deemed effective, the difference in %TBWL between the treatment group minus the control group must be significantly greater than 5%. | 12 months |
| Responder rate of at least 50% in the POSE2.0 treatment group | Responder defined as >5% TBWL | 12 months |
| Safety- Incidence of device and procedure related adverse events through 12 months | Incidence of device and procedure related adverse events through 12 months defined as Clavien-Dindo Class III or greater. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP of Medical Affairs | Contact | 949-369-3890 | info@usgimedical.com | |
| Director, RA/QA | Contact | 949-369-3890 | tpalmer@usgimedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Barham Abu Dayyeh, MD, MPH | Mayo Clinic | Principal Investigator |
| Erik Wilson, MD | University of Texas Medical School at Houston | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |