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The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study (BALOON Pilot)

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ClinicalTrials.gov Identifier: NCT03576833
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Michael Bretthauer, Oslo University Hospital

Brief Summary:

This protocol describes a feasibility pilot study preceding a randomized clinical study that aims at comparing the Elipse intragastric Balloon system to other invasive obesity techiniques.

The current pilot study is investigating the feasibility and efficacy of the Elipse Balloon system in 20 patients in Norway.


Condition or disease Intervention/treatment Phase
Obesity Device: Elipse Balloon system Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Balloon Device: Elipse Balloon system
intragastic balloon




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 4 months ]
    percentage of adequate balloon insertion and balloon excretion


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 4 months ]
    Weight in kg during intervention, and HBA1c values compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2 diabetes.

Exclusion Criteria:

  1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
  2. Previous bariatric or gastric surgery
  3. History of chronic or acute pancreatitis
  4. History of small bowel obstructions
  5. History of open abdominal and/or pelvic surgery EXCLUDING open appendectomy with a right lower quadrant incision.
  6. Thyroid or adrenal disease not controlled with medication
  7. History of/or signs and/or symptoms of esophageal, gastric, or duodenal disease such as dysphagia and/or painful swallowing, hiatal hernias >5 centimeter, paraesophageal hernias, chronic or acute inflammation, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, or achalasia
  8. Specific diagnosed genetic or hormonal cause for obesity such as Prader-Willi syndrome
  9. Severe coagulopathy, hepatic insufficiency or cirrhosis
  10. Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse deployment and continuing for 14 days after Elipse excretion
  11. Anemia defined as either Hgb <11 g/dL for females and <12 g/dL for males
  12. Inability to walk 200 meters without assistance
  13. Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
  14. Current or history of illicit drug use or excessive alcohol use
  15. Currently taking the following medications (within 30 days prior to enrolment) and/or anticipated need for these medications during the study: Systemic corticosteroids; anticoagulants (e.g. warfarin, dabigatran) or anti-platelet therapy; narcotics or opiates; anti-seizure medication (e.g. clonazepam, phenytoin)
  16. Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase (IA2) (MODY or type 1 diabetes)
  17. Any specified conditions that, in the opinion of the investigator, may render the subject unable to complete the study without a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
  18. Women in childbearing age must document a negative pregnancy test. Women must not be breast-feeding at the time of treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576833


Contacts
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Contact: Michael Bretthauer, MD PhD 90132480 michael.bretthauer@medisin.uio.no
Contact: Christer Tønnesen, MD christer.tonnesen@medisin.uio.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0318
Contact: Christer Tønnesen, MD       christer.tonnesen@medisin.uio.no   
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
University of Oslo

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Responsible Party: Michael Bretthauer, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03576833     History of Changes
Other Study ID Numbers: REK 2017/1574
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms