Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
NCT ID: NCT02129296
Last Updated: 2015-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
300 participants
INTERVENTIONAL
2013-09-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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hemiosphere® BALLOON
Balloon filled with air according to the manufacturing company orders 600 or 720 ml air
Air filled balloon
Balloon filled with air according to the manufacturing company orders
Fluid filled balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
Bioenteric BIB® balloon
Balloon filled with saline and methylene blue according to the manufacturing company orders
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non compliant patients
* Psychological patients
* Oesophageal varices, big hiatus hernia, ulcers
* Gastric vascular malformations
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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MOHAMED ABDELLATIF
PhD
Principal Investigators
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Mohamed E Abd Ellatif, PhD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Hafr Albatin Central hospital
Mansoura University, , Egypt
Countries
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Central Contacts
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mohamed e abd ellatif, PhD
Role: CONTACT
Facility Contacts
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mohamed e abd Ellatif, phd
Role: primary
Other Identifiers
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Gastric balloon
Identifier Type: -
Identifier Source: org_study_id
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