ObesityIGBNCT03233048
Intragastric Balloon in Obese Adolescents With Comorbidities
A study testing ORBERA™ Intragastric Balloon in people with Obesity, run by Imad Absah at 1 site in United States.
Trial summary
The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- ORBERA™ Intragastric Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI>35 kilogram per square meter (kg/m2) with one of the following severe comorbidities, both for at least 2 years:
- Type 2 diabetes mellitus
- Moderate-to-severe sleep apnea
- Pseudotumor cerebri
- Nonalcoholic Steatohepatitis (NASH) based on fatty infiltration of the liver with transaminitis that cannot be explained by other liver disease
- Or,
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- BMI>40 kilogram per square meter (kg/m2) with two or more of the following mild comorbidities, all for at least 2 years:
- Hypertension
- Dyslipidemia
- Mild obstructive sleep apnea
- Chronic venous insufficiency
- Panniculitis
- Urinary incontinence
- Nonalcoholic Steatohepatitis (NASH)
- Gastroesophageal reflux disease (GERD)
- Arthropathies related to weight
- In addition, all of the following inclusion criteria must be met. The subject must have:
- attained approximately 95% of adult stature, as demonstrated by Tanner Stage IV or more and growth charts demonstrating the taper/plateau of height as a marker for achieving 95% of the subject's adult stature. Height will be measured by trained staff to the nearest 0.1 cm using a stadiometer attached to a wall and documented in the subject's electronic medical record (EMR). In the absence of previous growth charts, skeletal maturity will be documented by a bone age of at least 13 years in girls and 15 years in boys; and
- failed to attain a healthy weight with at least one experience with medically supervised lifestyle changes, including physical activity and dietary interventions, which will be clearly documented in the subject's medical record, and
- demonstrated commitment to psychological evaluation perioperatively, in which the pediatric psychologist with expertise in childhood obesity must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study and has validated the Center for Epidemiology Study Depression (CES-D) scale and Spence Children's Anxiety Scale (SCAS) surveys completed by the subject, and
- agreed to avoid pregnancy for 1 year after intragastric balloon (IGB) placement through abstinence or approved contraception (female subjects only), and
- agreed to adhere to nutritional guidelines after intragastric balloon (IGB) placement, as provided by weight management clinic dietitian, and
- decisional capacity and desire to provide informed assent in conjunction with parent/guardian consent, and willingness to comply with all study requirements, and
- hypertension stage I: systolic blood pressure and/or diastolic blood pressure ≥ 95th percentile, OR high normal blood pressure between the 90th and 95th percentile.
Who cannot join
- Subjects will be excluded if:
- they are pregnant or breastfeeding, or
- there is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the use of the investigational device or that may affect the interpretation of the results or render the subject at high risk for treatment complications, or
- there is alcohol, tobacco, or substance use by the subject, or
- in the opinion of the principal investigator (PI) and/or co-investigators, subject or parent/guardian may be non-compliant with study schedules or procedures, or
- there are any endoscopic contraindications, including large hiatal hernia (≥ 2 cm), esophagitis of any degree, erosive gastritis, or ulceration of the stomach or duodenum, or
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- Helicobacter pylori (H. pylori) is detected via a fecal antigen study prior to initial endoscopic assessment (sensitivity > 96.8%); once treated, a repeat fecal antigen must be performed to document eradication prior to the first endoscopic approach for balloon placement, or
- they have hypertension stage II > 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
- Gastroesophageal reflux disease (GERD) subjects are on more than one medication or have a history of erosive esophagitis due to gastroesophageal reflux disease (GERD), or
- they have dyslipidemia, if part of hereditary metabolic syndrome or genetic disorder, or
- they have any gastrointestinal disease that can result in stomach ulcerations, such as Crohn's disease, celiac disease, eosinophilic esophagitis, acute or chronic pancreatitis or gastrinoma, or
- they have any endocrine disorders that affect metabolic status of the subjects, such as hypo/hyperthyroidism, type 1 diabetes, Cushing's disease, or adrenal insufficiency, as documented in the electronic medical record (EMR) through an evaluation by the pediatric endocrinologist who will order additional testing if needed, or
- they have prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions and/or history of abdominal and/or pelvic surgery which may cause adhesions (except one of the following: caesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy performed 12 or more months prior to balloon implantation), or
- they have prior open or laparoscopic bariatric surgery, or
- they have prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery, or
- they have any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, cancer or specific inflammation such as Crohn's disease, or
- they have potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses, or,
- they have a gastric mass, or
- they have acid reflux symptoms to any degree that require more than one medication for symptom control, or
- they have a structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope, or
- they have achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device, or
- they have severe coagulopathy, or
- they have poorly controlled diabetes, defined as having a Hemoglobin A1c (HgA1c) > 10, or
- they have serious health conditions unrelated to their weight that would increase the risk of endoscopy, or
- they have chronic abdominal pain, or
- they have motility disorders of the gastrointestinal (GI) tract such as gross esophageal motility disorders, gastroparesis, or intractable constipation, or
- they have hepatic insufficiency or cirrhosis, or
- they have serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits and removal of the device, or
- they are receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, or
- they are taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications, or
- they are taking corticosteroids, immunosuppressants, or narcotics, or
- they are unable or unwilling to take prescribed proton pump inhibitor medication, or
- they are known to have, or suspected to have, an allergic reaction to materials contained in the system, or
- they have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body (e.g. selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors), or
- they have a medically identifiable cause of obesity (specific diagnosed genetic or hormonal case for obesity such as hypothyroidism or Prader Willi syndrome), or
- they have known history of endocrine disorders affecting weight, or
- they use any medications, except for Metformin, known to affect body weight and carbohydrate or lipid metabolism, or
- they used an intragastric device prior to this study, or
- they participated in any clinical study which could affect weight loss within the past 6 months, or
- they have symptomatic congestive heart failure or cardiac arrhythmia, or
- they have a diagnosis of an autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma), or immunocompromised, or
- they are on insulin for type 2 diabetes and not proficient in self-monitoring capillary blood glucose testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Endoscopically Placed Intragastric Balloon in Obese Adolescents With Comorbidities - A Pilot Study
The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.
Read the detailed description
After obtaining consent and determining that participants meet the inclusion and exclusion criteria, participants will have baseline tests and initial visits with a physician, dietitian, and psychologist. Next, the ORBERA™ Intragastric Balloon (IGB) will be inserted into the stomach and then removed after 6 months. Participants will continue to be followed for 6 months after the balloon is removed. Throughout the year, participants will have additional tests along with ongoing visits with a physician, dietitian, and psychologist.
- Conditions
- Obesity
- Being tested
- ORBERA™ Intragastric Balloon
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORBERA™ Intragastric BalloonDevice
The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
| Study group | Role | What they receive |
|---|---|---|
| ORBERA™ Intragastric Balloon | Experimental | Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year. Receives: Device: ORBERA™ Intragastric Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss
Weight loss will be measured by change in weight divided by baseline weight.
Measured: up to 1 year
Secondary outcomes (10)
Change in Alanine Aminotransferase (ALT)
Change will be measured as a percentage by taking change in ALT divided by baseline ALT.
Measured: Baseline, end of study (approximately 1 year)
Change in Aspartate Aminotransferase (AST)
Change will be measured as a percentage by taking change in AST divided by baseline AST.
Measured: Baseline, end of study (approximately 1 year)
Change in Fasting Insulin
Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.
Measured: Baseline, end of study (approximately 1 year)
Change in Hemoglobin A1c (HgA1c)
Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.
Measured: Baseline, end of study (approximately 1 year)
Change in High-density Lipoprotein (HDL)
Change will be measured as a percentage by taking change in HDL divided by baseline HDL.
Measured: Baseline, end of study (approximately 1 year)
Change in Low-density Lipoprotein (LDL)
Change will be measured as a percentage by taking change in LDL divided by baseline LDL.
Measured: Baseline, end of study (approximately 1 year)
Change in Triglycerides
Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.
Measured: Baseline, end of study (approximately 1 year)
Number of Participants With One or More Serious Adverse Events
Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.
Measured: Intragastric balloon (IGB) removal (approximately 6 months)
Number of Subjects Who Had the Balloon Removed Early
Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.
Measured: Intragastric balloon (IGB) removal (approximately 6 months)
Number of Subjects Whose Balloon Deflated Early
Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.
Measured: Intragastric balloon (IGB) removal (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start26 Oct 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imad Absah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Imad Absah, Mayo Clinic
- Investigators
- Imad Absah, M.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233048
- Sponsor's protocol ID
- 15-009191
- Acronym
- IGB
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2017
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopically Placed Intragastric Balloon in Obese Adolescents With Comorbidities - A Pilot Study
- ClinicalTrials.gov ID
- NCT03233048
- Acronym / sponsor ID
- IGB / 15-009191
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Imad AbsahUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.
Detailed description
After obtaining consent and determining that participants meet the inclusion and exclusion criteria, participants will have baseline tests and initial visits with a physician, dietitian, and psychologist. Next, the ORBERA™ Intragastric Balloon (IGB) will be inserted into the stomach and then removed after 6 months. Participants will continue to be followed for 6 months after the balloon is removed. Throughout the year, participants will have additional tests along with ongoing visits with a physician, dietitian, and psychologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORBERA™ Intragastric Balloon | Experimental | Device: ORBERA™ Intragastric BalloonParticipants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- BMI>35 kilogram per square meter (kg/m2) with one of the following severe comorbidities, both for at least 2 years:
- Type 2 diabetes mellitus
- Moderate-to-severe sleep apnea
- Pseudotumor cerebri
- Nonalcoholic Steatohepatitis (NASH) based on fatty infiltration of the liver with transaminitis that cannot be explained by other liver disease
Key exclusion criteria (42 listed)
- they are pregnant or breastfeeding, or
- there is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the use of the investigational device or that may affect the interpretation of the results or render the subject at high risk for treatment complications, or
- there is alcohol, tobacco, or substance use by the subject, or
- in the opinion of the principal investigator (PI) and/or co-investigators, subject or parent/guardian may be non-compliant with study schedules or procedures, or
- there are any endoscopic contraindications, including large hiatal hernia (≥ 2 cm), esophagitis of any degree, erosive gastritis, or ulceration of the stomach or duodenum, or
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 |
|---|---|---|
| ORBERA™ Intragastric BalloonThe balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed. | Device | ORBERA™ Intragastric Balloon |
Primary outcome
Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss
Time frame: up to 1 year
Weight loss will be measured by change in weight divided by baseline weight.
10 secondary outcomes
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline, end of study (approximately 1 year)
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline, end of study (approximately 1 year)
Change in Fasting Insulin
Time frame: Baseline, end of study (approximately 1 year)
Change in Hemoglobin A1c (HgA1c)
Time frame: Baseline, end of study (approximately 1 year)
Change in High-density Lipoprotein (HDL)
Time frame: Baseline, end of study (approximately 1 year)
Change in Low-density Lipoprotein (LDL)
Time frame: Baseline, end of study (approximately 1 year)
Change in Triglycerides
Time frame: Baseline, end of study (approximately 1 year)
Number of Participants With One or More Serious Adverse Events
Time frame: Intragastric balloon (IGB) removal (approximately 6 months)
Number of Subjects Who Had the Balloon Removed Early
Time frame: Intragastric balloon (IGB) removal (approximately 6 months)
Number of Subjects Whose Balloon Deflated Early
Time frame: Intragastric balloon (IGB) removal (approximately 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Imad Absah, M.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORBERA™ Intragastric Balloon in people with Obesity, run by Imad Absah at 1 site in United States.
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 24 inclusion and 42 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 3 May 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss (time frame: up to 1 year). 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 3 May 2022.