Aspiration therapy in asian patients
This research project will provide insight into the efficacy and safety of aspiration therapy in the management of obesity and its comorbidities in the Asian population, and will determine if there is a role for this novel endoscopic device in the treatment algorithm of obesity in the investigators' local regions.
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment
Intervention:
|
Device: Aspiration Therapy (AspireAssist®)
Use of the AspireAssist device in aspiration therapy
Other Name: AspireAssist® Aspiration Therapy System
Behavioral: Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Name: Lifestyle Behavioral Therapy
|
| Active Comparator: Control
Intervention: (1) Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy - Subjects randomized to the control group will receive lifestyle management matched to the treatment group in the first year. At the end of one year, they will be crossed over to treatment and the A-tube will be inserted. They will then follow up the same follow up schedule of the treatment group during the first year. |
Device: Aspiration Therapy (AspireAssist®)
Use of the AspireAssist device in aspiration therapy
Other Name: AspireAssist® Aspiration Therapy System
Behavioral: Lifestyle Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
Other Name: Lifestyle Behavioral Therapy
|
| Category | Value |
|---|---|
| Date last updated at source | 2016-08-23 |
| Study type(s) | Randomised clinical trial |
| Expected enrolment | 15 |
| Study start date | 2016-08-01 |
| Estimated primary completion date | 2018-12-01 |