ObesityNCT02556138
Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
A study testing ORBERA Intragastric Balloon in people with Obesity and Liver Cirrhosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Liver Cirrhosis
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 3 Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with end-stage liver disease who are listed for liver transplant
- Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of >5 kg)
- Body Mass Index (BMI) >35
- Negative pregnancy test for females who are able to get pregnant and are of child-bearing age
Who cannot join
- A previous history of gastric or bariatric surgery
- Current or recent (within 6 months) gastric or duodenal ulcers
- Moderate to severe Portal hypertension defined as portal gastropathy graded as >= to moderate/severe, gastric varices, or esophageal varices graded > = moderate/large (Patients with varices which have been obliterated may be included).
- Calculated Model of End-stage Liver Disease (MELD) score >25 or childs score >10
- The presence of more than one gastric balloon at the same time
- Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
Show all 17Show fewer
- A large hiatal hernia or >5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
- Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
- Gastric mass
- Severe coagulopathy
- Patients who are known to have or suspected to have an allergic reaction to materials contained in ORBERA.
- Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
- Alcoholism or drug addiction
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
- Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.
Read the detailed description
The prevalence of obesity and non-alcoholic steatohepatitis (NASH) in the general population is increasing. More and more patients with underlying NASH-related cirrhosis are now being referred to transplant centers but are not candidates for a potentially lifesaving liver transplantation due to their obesity and comorbidities related to the obesity.
The investigators proposed a clinical pilot study using the new FDA approved intragastric balloon in obese patients (BMI >35) with cirrhosis in need of liver transplantation, to assess weight loss and metabolic improvement.
The ORBERA™ Intragastric Balloon is an elastic spherical balloon made of silicone, filled with 650ml of saline solution. The deflated balloon comes preloaded on a catheter, which is advanced transorally into the stomach. An endoscope is then advanced alongside it to ensure accurate placement of the balloon in the fundus. Under direct visualization, the balloon is then inflated by injecting saline solution mixed with methylene blue through the external portion of the catheter. The ORBERA™ Intragastric Balloon is implanted for 6 months and then retrieved endoscopically by puncturing the balloon with a needle, emptying the fluid content, and removing it through the mouth. Both placement and removal of the ORBERA™ Balloon are done as an outpatient procedure with monitored or general anesthesia.
- Conditions
- Obesity, Liver Cirrhosis
- Being tested
- ORBERA Intragastric Balloon
- Keywords
- Intragastric Balloon, ORBERA Intragastric Balloon, Weight Loss, BMI >35
- Medical subject headings
- Obesity, Liver Cirrhosis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORBERA Intragastric BalloonDevice
The ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
| Study group | Role | What they receive |
|---|---|---|
| Orbera Intragastric Balloon | Experimental | All subjects will be receiving the ORBERA Intragastric Balloon 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 With >= 15% Excess Body Weight Loss at 6 Months
The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.
Measured: 6 months
Secondary outcomes (2)
Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal
%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg
Measured: 6 months
Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal
The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.
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 posted22 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion3 Nov 2016
- Study completion3 Nov 2016
Why it stopped: Unable to obtain a timely newly requested IDE
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.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kymberly D. Watt, Mayo Clinic
- Investigators
- Kymberly Watt, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556138
- Sponsor's protocol ID
- 15-003183
- Status last verified
- Jan 2018
- First submitted
- 18 Sep 2015
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
- ClinicalTrials.gov ID
- NCT02556138
- Acronym / sponsor ID
- 15-003183
- Conditions
- Obesity, Liver Cirrhosis
- Keywords
- Intragastric Balloon, ORBERA Intragastric Balloon, Weight Loss, BMI >35
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to obtain a timely newly requested IDE
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 3 Nov 2016 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.
Detailed description
The prevalence of obesity and non-alcoholic steatohepatitis (NASH) in the general population is increasing. More and more patients with underlying NASH-related cirrhosis are now being referred to transplant centers but are not candidates for a potentially lifesaving liver transplantation due to their obesity and comorbidities related to the obesity.
The investigators proposed a clinical pilot study using the new FDA approved intragastric balloon in obese patients (BMI >35) with cirrhosis in need of liver transplantation, to assess weight loss and metabolic improvement.
The ORBERA™ Intragastric Balloon is an elastic spherical balloon made of silicone, filled with 650ml of saline solution. The deflated balloon comes preloaded on a catheter, which is advanced transorally into the stomach. An endoscope is then advanced alongside it to ensure accurate placement of the balloon in the fundus. Under direct visualization, the balloon is then inflated by injecting saline solution mixed with methylene blue through the external portion of the catheter. The ORBERA™ Intragastric Balloon is implanted for 6 months and then retrieved endoscopically by puncturing the balloon with a needle, emptying the fluid content, and removing it through the mouth. Both placement and removal of the ORBERA™ Balloon are done as an outpatient procedure with monitored or general anesthesia.
Study design
- Primary purpose
- Supportive care
- 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 BalloonAll subjects will be receiving the ORBERA Intragastric Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with end-stage liver disease who are listed for liver transplant
- Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of >5 kg)
- Body Mass Index (BMI) >35
- Negative pregnancy test for females who are able to get pregnant and are of child-bearing age
Key exclusion criteria (17 listed)
- A previous history of gastric or bariatric surgery
- Current or recent (within 6 months) gastric or duodenal ulcers
- Moderate to severe Portal hypertension defined as portal gastropathy graded as >= to moderate/severe, gastric varices, or esophageal varices graded > = moderate/large (Patients with varices which have been obliterated may be included).
- Calculated Model of End-stage Liver Disease (MELD) score >25 or childs score >10
- The presence of more than one gastric balloon at the same time
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 ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically. | Device | Orbera Intragastric Balloon |
Primary outcome
Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months
Time frame: 6 months
The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.
2 secondary outcomes
Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal
Time frame: 6 months
Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kymberly Watt, M.D. principal investigator
Mayo Clinic
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 and Liver Cirrhosis, run by Mayo Clinic 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 4 inclusion and 17 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: stopped early, as of the sponsor's last update on 30 Jan 2018. 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 30 Jan 2018). 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 With >= 15% Excess Body Weight Loss at 6 Months (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 30 Jan 2018.