Comparison of Gastric Bypass and AspireAssist Aspiration Therapy for Treatment of Morbid Obesity
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|ClinicalTrials.gov Identifier: NCT02142257|
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment|
|Obesity||Procedure: Gastric Bypass Device: AspireAssist Aspiration Therapy|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study Over 5 Years|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Morbidly obese individuals who meet the criteria for and have chosen to undergo Gastric Bypass surgery.
Procedure: Gastric Bypass
Gastric Bypass surgery reduces the size of the stomach by use of staples. The smaller gastric pouch is then connected to the intestine bypassing a portion of the small intestine.
AspireAssist Aspiration Therapy
Morbidly obese individuals who meet the criteria for and have chosen to participate in Aspiration Therapy using the AspireAssist.
Device: AspireAssist Aspiration Therapy
AspireAssist employs an endoscopically placed A-Tube (similar to a gastrostomy tube) and a Companion system which facilitates portion control by aspiration of stomach contents 20 minutes after each meal combined with behavioral Therapy.
- Weight Loss [ Time Frame: year 1 - quarterly, years 2-5 once per year ]% Excess Weight loss based on ideal body weight with BMI of 25
- Quality of Life [ Time Frame: annually, up to 5 years ]Quality of Life survey according to EQ-5D EuroQol survey
- Complications [ Time Frame: within 30 days of procedure, after 30 days ]any surgical or post surgical complications, therapy related illness or adverse events
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): NCT02142257
|Blekinge County Council Hospital|
|Karlskrona, Sweden, 371 85|
|Principal Investigator:||Max O Nystrom, MD||Blekinge County Council Hospital|