NCT02129296

Brief 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.

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 phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

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

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

April 26, 2014

Last Update Submit

April 7, 2015

Conditions

Morbid ObesityWeight LossTolerance

Keywords

Morbid obesityGastric balloonWeight lossToleranceSafety

Outcome Measures

Primary Outcomes (1)

  • Tolerance

    Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia

    6 months

Secondary Outcomes (2)

  • Weight loss

    6 months

  • Rate of deflation or puncture

    6 MONTHS

Study Arms (2)

hemiosphere® BALLOON

ACTIVE COMPARATOR

Balloon filled with air according to the manufacturing company orders 600 or 720 ml air

Device: Air filled balloon

Fluid filled balloon

ACTIVE COMPARATOR

Balloon filled with saline and methylene blue according to the manufacturing company orders

Device: Bioenteric BIB® balloon

Interventions

Air filled balloonDEVICE

Balloon filled with air according to the manufacturing company orders

Also known as: first group
hemiosphere® BALLOON
Bioenteric BIB® balloonDEVICE

Balloon filled with saline and methylene blue according to the manufacturing company orders

Also known as: second group
Fluid filled balloon

Eligibility Criteria

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

You may qualify if:

  • Morbidly obese patients

You may not qualify if:

  • Patient refused
  • Non compliant patients
  • Psychological patients
  • Oesophageal varices, big hiatus hernia, ulcers
  • Gastric vascular malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafr Albatin Central hospital

Mansoura University, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Mohamed E Abd Ellatif, PhD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed e abd ellatif, PhD

CONTACT

0543973660

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 2, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)