Obesity Clinical Trial
— BALOON PilotOfficial title:
The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
Verified date | June 2020 |
Source | Norwegian Department of Health and Social Affairs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Norwegian Department of Health and Social Affairs | University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate insertion | percentage of adequate balloon insertion and balloon excretion | 4 months | |
Secondary | weight loss | Weight in kg during intervention, and HBA1c values compared to baseline | 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |