Effect of Gastric Balloon in Morbid Obesity: Prospective... | NCT02128165

Studies
Effect of Gastric Balloon in Morbid Obesity: Prospective Study

NCT02128165

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Apr 8, 2015Estimated

Enrollment

300Estimated

Phase

Phase 1Phase 2

Conditions

Morbid Obesity

Interventions

BMI more than 45 BMI
BMI less than 45 BMI

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Apr 26, 2014

First Submission Date that Met QC Criteria

Apr 30, 2014

First Posted Date

May 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2015

Last Update Posted Date

Apr 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BMI more than 45 BMI	Device	Air filled gastric balloon (Heliosphere) those BMI above 45	BMI more than 45 BMI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of weight loss	By following up the BMI every month	6 months

Secondary Outcomes

Measure	Description	Time Frame
Tolerance	Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbid obesity

Exclusion Criteria:

patient refusal
psychological patients
oesophageal or gastric abnormalities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed e abd ellatif, phd	Contact	0543973660

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University	Recruiting	Al Mansurah			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided