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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
Sponsor:
Information provided by (Responsible Party):
Max O Nystrom, Blekinge County Council Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy over 5 years of treatment with regards to weight loss, quality of life, complications, adverse events, and health economics.

Condition or disease Intervention/treatment
Obesity Procedure: Gastric Bypass Device: AspireAssist Aspiration Therapy

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Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Groups and Cohorts
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Group/Cohort Intervention/treatment
Gastric Bypass
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: annually, up to 5 years ]
    Quality of Life survey according to EQ-5D EuroQol survey


Other Outcome Measures:
  1. Complications [ Time Frame: within 30 days of procedure, after 30 days ]
    any surgical or post surgical complications, therapy related illness or adverse events


Eligibility Criteria
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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
Study Population
The study is a prospective investigation of patients in Blekinge with a diagnosis of obesity. A total of 100 patients will be included consecutively in the study. The distribution will be 50 patients for each group. Recruitment for Gastric Bypass is made from the clinic's waiting list for obesity surgery and for AspireAssist those individuals' self-reported interest for treatment with AspireAssist.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sweden
Blekinge County Council Hospital
Karlskrona, Sweden, 371 85
Sponsors and Collaborators
Blekinge County Council Hospital
Investigators
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Principal Investigator: Max O Nystrom, MD Blekinge County Council Hospital
More Information
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Responsible Party: Max O Nystrom, Dr Max O Nystrom, Blekinge County Council Hospital
ClinicalTrials.gov Identifier: NCT02142257     History of Changes
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.
Keywords provided by Max O Nystrom, Blekinge County Council Hospital:
Obesity
Gastric Bypass
Aspiration Therapy
AspireAssist
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms