NCT02136173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

May 7, 2014

Last Update Submit

April 7, 2015

Conditions

Weight LossBalloon

Outcome Measures

Primary Outcomes (1)

  • weight loss

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

    12 months

Study Arms (1)

sequential balloons

EXPERIMENTAL

effect of weight loss by applying sequential balloons

Device: Heliosphere bag (air filled balloon)

Interventions

Heliosphere bag (air filled balloon)DEVICE

sequential balloons . Heliosphere bag (air filled balloon)

sequential balloons

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed e abd ellatif, PhD

CONTACT

0543973660

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 12, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)