Back to resultsIntragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Primary Purpose
Morbid Obesity, Weight Loss, Tolerance
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Air filled balloon
Bioenteric BIB® balloon
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety
Eligibility Criteria
Inclusion Criteria:
- Morbidly obese patients
Exclusion Criteria:
- Patient refused
- Non compliant patients
- Psychological patients
- Oesophageal varices, big hiatus hernia, ulcers
- Gastric vascular malformations
Sites / Locations
- Hafr Albatin Central hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hemiosphere® BALLOON
Fluid filled balloon
Arm Description
Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
Balloon filled with saline and methylene blue according to the manufacturing company orders
Outcomes
Primary Outcome Measures
Tolerance
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
Secondary Outcome Measures
Weight loss
Weight loss by Kg and BMI,
Rate of deflation or puncture
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02129296
Brief Title
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Official Title
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Weight Loss, Tolerance
Keywords
Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hemiosphere® BALLOON
Arm Type
Active Comparator
Arm Description
Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
Arm Title
Fluid filled balloon
Arm Type
Active Comparator
Arm Description
Balloon filled with saline and methylene blue according to the manufacturing company orders
Intervention Type
Device
Intervention Name(s)
Air filled balloon
Other Intervention Name(s)
first group
Intervention Description
Balloon filled with air according to the manufacturing company orders
Intervention Type
Device
Intervention Name(s)
Bioenteric BIB® balloon
Other Intervention Name(s)
second group
Intervention Description
Balloon filled with saline and methylene blue according to the manufacturing company orders
Primary Outcome Measure Information:
Title
Tolerance
Description
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight loss
Description
Weight loss by Kg and BMI,
Time Frame
6 months
Title
Rate of deflation or puncture
Description
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
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Morbidly obese patients
Exclusion Criteria:
Patient refused
Non compliant patients
Psychological patients
Oesophageal varices, big hiatus hernia, ulcers
Gastric vascular malformations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed e abd ellatif, PhD
Phone
0543973660
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed E Abd Ellatif, PhD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafr Albatin Central hospital
City
Mansoura University
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed e abd Ellatif, phd
Phone
0543973660
12. IPD Sharing Statement
Learn more about this trial
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
We'll reach out to this number within 24 hrs