Cross-over arm of the pilot study evaluating a treatment for obesity.
This is a multi-center, open-label, cross-over arm from the 2-group randomized pilot study evaluating a treatment for obesity. The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program. 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). Efficacy will be evaluated based on changes in weight loss through 12 months. Adverse events will be recorded throughout the duration of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
The intent is to evaluate the safety and preliminary efficacy of a new Snowshoe suture placement pattern, POSE2.0 (sutures placed in the mid + distal body without fundus), with a moderate intensity diet and exercise program.
Mayo Clinic
Rochester, Minnesota, United States
Mean Percent TBWL at 3 months
Mean Percent TBWL at 3 months.
Time frame: 3 months.
Mean Percent TBWL at 12 months
Mean Percent TBWL at 12 months.
Time frame: 12 months.
Percentage of subjects with ≥5% TBWL at 3 months
Percentage of subjects with ≥5% TBWL at 3 months.
Time frame: 3 months.
Percentage of subjects with ≥5% TBWL at 12 months
Percentage of subjects with ≥5% TBWL at 12 months.
Time frame: 12 months.
Overall incidence of device and procedure related adverse events through 12 months
Overall incidence of device and procedure related adverse events through 12 months.
Time frame: 12 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 3 months in Percent EWL
Time frame: Change from baseline at 3 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 12 months in Percent EWL
Time frame: Change from baseline at 12 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 3 months in BMI reduction
Time frame: Change from baseline at 3 months
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To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 12 months in BMI reduction
Time frame: Change from baseline at 12 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 3 months in weight loss (lb/kg)
Time frame: Change from baseline at 3 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 12 months in weight loss (lb/kg)
Time frame: Change from baseline at 12 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 3 months in waist circumference
Time frame: Change from baseline at 3 months
To investigate observational efficacy objectives of the POSE2.0 procedure
Change from baseline at 12 months in waist circumference
Time frame: Change from baseline at 12 months
Change from baseline at 12 months in Quality of Life Scores
The IWQOL-Lite questionnaire is a validated, 31-item, self-report measure of obesity-specific quality of life. In addition to a total score, there are scores on five domains: Physical function; Self-esteem; Sexual life; Public distress; Work.
Time frame: Change from baseline at 12 months
Change from baseline at 12 months in Co-morbidities
Change from baseline at 12 months in Co-morbidities.
Time frame: Change from baseline at 12 months
Change from baseline at 12 months in liver function
Liver function panel will be administered at baseline and at 12 months to assess change in liver function.
Time frame: Change from baseline at 12 months