ObesityNCT01444274
Pilot Study to Evaluate A Novel Gastric Space Occupying Device
An observational study of Obesity, run by Obalon Therapeutics, Inc. at 1 site in Mexico.
Trial summary
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- Obalon Gastric Balloon(s)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2011to Sep 2011
- Phase
- Observational
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Overweight or obese individuals who have failed routine dieting in the past
Who may be able to join
- Age between 21-64 years
- BMI 27-40 Kg/m2
- No history of weight reduction of more than 5% of total body weight in the past 6 months
Who cannot join
- Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
- Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
- Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
- Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
- History or symptoms of thyroid disease which is not controlled by medication;
- Have severe renal, hepatic, pulmonary disease or cancer;
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- Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
- Have a history of adhesive peritonitis;
- History or symptoms of esophageal and/or gastric varices;
- Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
- History or symptoms of inflammatory bowel disease, such as Chron's disease;
- History of/ signs and /or symptoms of duodenal or gastric ulcer;
- Have gastroparesis;
- Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
- Currently using pharmaceutical agents for weight loss;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.
- Conditions
- Obesity
- Being tested
- Obalon Gastric Balloon(s)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obalon Gastric Balloon(s)Device
One or two balloons administered per patient
| Study group | Role | What they receive |
|---|---|---|
| Obalon Gastric Balloon | One or two balloons administered to each patient Receives: Device: Obalon Gastric Balloon(s) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obalon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariel Ortiz Lagardere, MD, Principal investigator, Obesity Control Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444274
- Sponsor's protocol ID
- PTL-1000-0012
- Status last verified
- Mar 2019
- First submitted
- 28 Sep 2011
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
- ClinicalTrials.gov ID
- NCT01444274
- Acronym / sponsor ID
- PTL-1000-0012
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Obalon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Sep 2011 (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.
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obalon Gastric Balloon | – | Device: Obalon Gastric Balloon(s)One or two balloons administered to each patient |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overweight or obese individuals who have failed routine dieting in the past
Key inclusion criteria (3 listed)
- Age between 21-64 years
- BMI 27-40 Kg/m2
- No history of weight reduction of more than 5% of total body weight in the past 6 months
Key exclusion criteria (15 listed)
- Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
- Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
- Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
- Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
- History or symptoms of thyroid disease which is not controlled by medication;
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 |
|---|---|---|
| Obalon Gastric Balloon(s)One or two balloons administered per patient | Device | Obalon Gastric Balloon |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Obesity
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.
Ariel Ortiz Lagardere, MD principal investigator
Obesity Control Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Obalon Therapeutics, Inc. at 1 site in Mexico.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 15 Mar 2019. 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 Mexico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 15 Mar 2019.