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NCT02129296 Clinical Trial

Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Weight Loss Clinical Trial

Official title:
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02129296
Other study ID # Gastric balloon
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received April 26, 2014
Last updated April 7, 2015
Start date September 2013
Est. completion date August 2016

Study information
Verified date April 2015
Source Mansoura University
Contact mohamed e abd ellatif, PhD
Phone 0543973660
Is FDA regulated No
Health authority Saudia Arabia: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Morbidly obese patients

Exclusion Criteria:

- Patient refused

- Non compliant patients

- Psychological patients

- Oesophageal varices, big hiatus hernia, ulcers

- Gastric vascular malformations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Air filled balloon
Balloon filled with air according to the manufacturing company orders
• Bioenteric BIB® balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders

Locations
Country Name City State
Egypt Hafr Albatin Central hospital Mansoura University

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerance Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia 6 months Yes
Secondary Weight loss Weight loss by Kg and BMI, 6 months Yes
Secondary 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 6 MONTHS Yes
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