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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02128165
Other study ID # Air gastric balloon
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received April 26, 2014
Last updated April 7, 2015
Start date August 2013
Est. completion date December 2016

Study information

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

Clinical Trial Summary

The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.


Description:

To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.


Recruitment information / eligibility

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

- morbid obesity

Exclusion Criteria:

- patient refusal

- psychological patients

- oesophageal or gastric abnormalities

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
BMI more than 45 BMI
Air filled gastric balloon (Heliosphere) those BMI above 45
BMI less than 45 BMI
Air filled gastric balloon (Heliosphere) those BMI below 45

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of weight loss By following up the BMI every month 6 months Yes
Secondary Tolerance Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain 6 months Yes
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