A Feasibility Study for the Treatment of Primary Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03837691|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Placement of Snowshoe Suture Anchors Behavioral: Moderate Intensity Diet & Exercise Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Five Patient Study|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study Examining Safety and Preliminary Effectiveness of a Procedural Technique Using an Endoscopic Suturing Device and Associated Devices for the Treatment of Primary Obesity|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: g-Cath EZ
Placement of Snowshoe suture anchors from g-Cath EZ Delivery Catheters, in a defined pattern in the mid and distal portions of the stomach, along with a moderate intensity diet & exercise program, to treat primary obesity.
Device: Placement of Snowshoe Suture Anchors
Snowshoe suture anchors from g-Cath EZ Delivery Catheters are placed in the stomach with the aid of a Transport, g-Lix and g-Prox device
Behavioral: Moderate Intensity Diet & Exercise Program
After placement of the snowshoe suture anchors in the stomach, subjects are asked to follow a moderate intensity diet and exercise program
- Primary weight loss intervention [ Time Frame: 12 months ]To evaluate the safety and preliminary effectiveness of the Pose 2 procedure using the g-Cath EZ Suture Anchor Delivery Catheter as a primary weight loss intervention.
- Changes in gastric emptying [ Time Frame: 2 & 6 months ]To gather information on changes in gastric emptying breath test findings in order to correlate changes with weight loss outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837691
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Barham Abu Dayyeh, MD||Mayo|