Morbid ObesityPhase 1/2NCT02129296
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
A Phase 1/2 study testing Air filled balloon and Bioenteric BIB® balloon in people with Morbid Obesity and Weight Loss, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Weight Loss, Tolerance
- What is being tested?
- Air filled balloon and Bioenteric BIB® balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2013to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Morbidly obese patients
Who cannot join
- Patient refused
- Non compliant patients
- Psychological patients
- Oesophageal varices, big hiatus hernia, ulcers
- Gastric vascular malformations
Trial locations and contacts
1 site in 1 country.
mohamed e abd ellatif, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Hafr Albatin Central hospital
Mansoura University
mohamed e abd Ellatif, phd, 0543973660
About this study
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.
Read the detailed description
Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.
- Conditions
- Morbid Obesity, Weight Loss, Tolerance
- Being tested
- Air filled balloon, Bioenteric BIB® balloon
- Keywords
- Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air filled balloonDevice
Also called first group
Balloon filled with air according to the manufacturing company orders
Bioenteric BIB® balloonDevice
Also called second group
Balloon filled with saline and methylene blue according to the manufacturing company orders
| Study group | Role | What they receive |
|---|---|---|
| hemiosphere® BALLOON | Active comparator | Balloon filled with air according to the manufacturing company orders 600 or 720 ml air Receives: Device: Air filled balloon |
| Fluid filled balloon | Active comparator | Balloon filled with saline and methylene blue according to the manufacturing company orders Receives: Device: Bioenteric BIB® balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
Measured: 6 months
Secondary outcomes (2)
Weight loss
Weight loss by Kg and BMI,
Measured: 6 months
Rate of deflation or puncture
Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
- Investigators
- Mohamed E Abd Ellatif, PhD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129296
- Sponsor's protocol ID
- Gastric balloon
- Status last verified
- Apr 2015
- First submitted
- 26 Apr 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02129296
- Acronym / sponsor ID
- Gastric balloon
- Conditions
- Morbid Obesity, Weight Loss, Tolerance
- Keywords
- Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemiosphere® BALLOON | Active comparator | Device: Air filled balloonBalloon filled with air according to the manufacturing company orders 600 or 720 ml air |
| Fluid filled balloon | Active comparator | Device: Bioenteric BIB® balloonBalloon filled with saline and methylene blue according to the manufacturing company orders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Morbidly obese patients
Key exclusion criteria (5 listed)
- Patient refused
- Non compliant patients
- Psychological patients
- Oesophageal varices, big hiatus hernia, ulcers
- Gastric vascular malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air filled balloonAlso: first groupBalloon filled with air according to the manufacturing company orders | Device | hemiosphere® BALLOON |
| Bioenteric BIB® balloonAlso: second groupBalloon filled with saline and methylene blue according to the manufacturing company orders | Device | Fluid filled balloon |
Primary outcome
Tolerance
Time frame: 6 months
Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia
2 secondary outcomes
Weight loss
Time frame: 6 months
Rate of deflation or puncture
Time frame: 6 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed e abd ellatif, PhD contact
Mohamed E Abd Ellatif, PhD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Air filled balloon and Bioenteric BIB® balloon in people with Morbid Obesity and Weight Loss, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed e abd ellatif, PhD (0543973660), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.