Morbid ObesityPhase 1/2NCT02128165
Effect of Gastric Balloon in Morbid Obesity: Prospective Study
A Phase 1/2 study testing BMI more than 45 BMI and BMI less than 45 BMI in people with Morbid Obesity, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- BMI more than 45 BMI and BMI less than 45 BMI
- 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
- Aug 2013to Dec 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
- morbid obesity
Who cannot join
- patient refusal
- psychological patients
- oesophageal or gastric abnormalities
Trial locations and contacts
1 site in 1 country.
mohamed e abd ellatif, phd contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah
mohamed e abd Ellatif, phd, 0543973660
About this study
The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.
Read the detailed description
To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.
- Conditions
- Morbid Obesity
- Being tested
- BMI more than 45 BMI, BMI less than 45 BMI
- Keywords
- gastric balloon, morbid obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI more than 45 BMIDevice
Air filled gastric balloon (Heliosphere) those BMI above 45
BMI less than 45 BMIDevice
Air filled gastric balloon (Heliosphere) those BMI below 45
| Study group | Role | What they receive |
|---|---|---|
| BMI more than 45 BMI | Active comparator | Air filled gastric balloon (Heliosphere) those BMI above 45 Receives: Device: BMI more than 45 BMI |
| BMI less than 45 BMI | Active comparator | Air filled gastric balloon (Heliosphere)those BMI below 45 Receives: Device: BMI less than 45 BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of weight loss
By following up the BMI every month
Measured: 6 months
Secondary outcomes (1)
Tolerance
Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain
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 posted1 May 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128165
- Sponsor's protocol ID
- Air 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
- Effect of Gastric Balloon in Morbid Obesity: Prospective Study
- ClinicalTrials.gov ID
- NCT02128165
- Acronym / sponsor ID
- Air gastric balloon
- Conditions
- Morbid Obesity
- Keywords
- gastric balloon, morbid obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI more than 45 BMI | Active comparator | Device: BMI more than 45 BMIAir filled gastric balloon (Heliosphere) those BMI above 45 |
| BMI less than 45 BMI | Active comparator | Device: BMI less than 45 BMIAir filled gastric balloon (Heliosphere)those BMI below 45 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- morbid obesity
Key exclusion criteria (3 listed)
- patient refusal
- psychological patients
- oesophageal or gastric abnormalities
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 |
|---|---|---|
| BMI more than 45 BMIAir filled gastric balloon (Heliosphere) those BMI above 45 | Device | BMI more than 45 BMI |
| BMI less than 45 BMIAir filled gastric balloon (Heliosphere) those BMI below 45 | Device | BMI less than 45 BMI |
Primary outcome
Effect of weight loss
Time frame: 6 months
By following up the BMI every month
1 secondary outcome
Tolerance
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
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 BMI more than 45 BMI and BMI less than 45 BMI in people with Morbid Obesity, 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 3 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?
Effect of weight loss (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.