Comparison of Gastric Bypass and AspireAssist Aspiration Therapy for Treatment of Morbid Obesity
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ClinicalTrials.gov Identifier: NCT02142257 |
Recruitment Status : Unknown
Verified April 2018 by Max O Nystrom, Blekinge County Council Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : April 30, 2018
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Condition or disease | Intervention/treatment |
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Obesity | Procedure: Gastric Bypass Device: AspireAssist Aspiration Therapy |

Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Gastric Bypass
Morbidly obese individuals who meet the criteria for and have chosen to undergo Gastric Bypass surgery.
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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.
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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

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- age 20-60 years
- body mass index over 35
- the absence of an eating disorder
- severe co-morbidity
- failure to achieve weight loss with lifestyle changes or other conservative approaches
Exclusion Criteria:
- Recent myocardial infarction (3 months)
- Ongoing cancer
- Chronic liver and / or kidney disease
- Mental illness, including substance abuse and eating disorders that can exclude the patient from aspiration therapy.
- Discovery of severe disease of the stomach on endoscopy

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
Sweden | |
Blekinge County Council Hospital | |
Karlskrona, Sweden, 371 85 |
Principal Investigator: | Max O Nystrom, MD | Blekinge County Council Hospital |
Responsible Party: | Max O Nystrom, Dr Max O Nystrom, Blekinge County Council Hospital |
ClinicalTrials.gov Identifier: | NCT02142257 |
Other Study ID Numbers: |
2013/12 |
First Posted: | May 20, 2014 Key Record Dates |
Last Update Posted: | April 30, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share individual participant data. |
Obesity Gastric Bypass Aspiration Therapy AspireAssist |
Obesity Obesity, Morbid Overnutrition |
Nutrition Disorders Overweight Body Weight |