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Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02129296
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
35
Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Condition or Disease Intervention/Treatment Phase
  • Device: Air filled balloon
  • Device: Bioenteric BIB® balloon
 Phase 1/Phase 2

Detailed Description

Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: hemiosphere® BALLOON

Balloon filled with air according to the manufacturing company orders 600 or 720 ml air

Device: Air filled balloon
Balloon filled with air according to the manufacturing company orders
Other Names:
  • first group

    		•
    Active Comparator: Fluid filled balloon

    Balloon filled with saline and methylene blue according to the manufacturing company orders

    Device: Bioenteric BIB® balloon
    Balloon filled with saline and methylene blue according to the manufacturing company orders
    Other Names:
  • second group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tolerance [6 months]

      Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia

    Secondary Outcome Measures

    1. Weight loss [6 months]

      Weight loss by Kg and BMI,

    2. Rate of deflation or puncture [6 MONTHS]

      Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Morbidly obese patients
    Exclusion Criteria:

    • Patient refused

    • Non compliant patients

    • Psychological patients

    • Oesophageal varices, big hiatus hernia, ulcers

    • Gastric vascular malformations

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hafr Albatin Central hospital Mansoura University Egypt

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Principal Investigator: Mohamed E Abd Ellatif, PhD, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MOHAMED ABDELLATIF, PhD, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT02129296
    Other Study ID Numbers:
    • Gastric balloon
    First Posted:
    May 2, 2014
    Last Update Posted:
    Apr 8, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by MOHAMED ABDELLATIF, PhD, Mansoura University
    Morbid obesity
    Gastric balloon
    Weight loss
    Tolerance
    Safety
    Additional relevant MeSH terms:
    Obesity, Morbid
    Weight Loss

    Study Results

    No Results Posted as of Apr 8, 2015