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Clinical Trials/NCT02136173
NCT02136173UnknownNot Applicable

Study of Weight Loss Effect of the Sequential Balloons

Mansoura University1 site in 1 country300 target enrollmentStarted: December 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
weight loss
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The effect of the balloon on weight loss is investigated by multiple studies. However, the effect of the sequential balloons is not studied yet.

Detailed Description

We are aiming to study the effect of the sequential balloons in the patients who had weight loss with the first balloon and they need subsequent balloons to have more weight loss after their first balloons are removed after 6 months.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •BMI > 45 and weight >120 Kg
  • •Patients refused to have bariatric surgery.

Exclusion Criteria

  • •Esophageal or gastric or duodenal lesions.
  • •Bleeding disorders.
  • •uncooperative patients.

Arms & Interventions

sequential balloons

Experimental

effect of weight loss by applying sequential balloons

Intervention: Heliosphere bag (air filled balloon) (Device)

Outcomes

Primary Outcomes

weight loss

Time Frame: 12 months

study the weight loss in form of KG and BMI before balloon, 6 months after and 12 months after

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MOHAMED ABDELLATIF

PHD

Mansoura University

Study Sites (1)

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