NCT02128165

Brief 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.

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 Aug 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

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 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

3.3 years

First QC Date

April 26, 2014

Last Update Submit

April 7, 2015

Conditions

Morbid Obesity

Keywords

gastric balloonmorbid obesity

Outcome Measures

Primary Outcomes (1)

  • Effect of weight loss

    By following up the BMI every month

    6 months

Secondary Outcomes (1)

  • Tolerance

    6 months

Study Arms (2)

BMI more than 45 BMI

ACTIVE COMPARATOR

Air filled gastric balloon (Heliosphere) those BMI above 45

Device: BMI more than 45 BMI

BMI less than 45 BMI

ACTIVE COMPARATOR

Air filled gastric balloon (Heliosphere)those BMI below 45

Device: BMI less than 45 BMI

Interventions

BMI more than 45 BMIDEVICE

Air filled gastric balloon (Heliosphere) those BMI above 45

BMI more than 45 BMI
BMI less than 45 BMIDEVICE

Air filled gastric balloon (Heliosphere) those BMI below 45

BMI less than 45 BMI

Eligibility Criteria

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

You may qualify if:

  • morbid obesity

You may not qualify if:

  • patient refusal
  • psychological patients
  • oesophageal or gastric abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed e abd ellatif, phd

CONTACT

0543973660

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
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 1, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)