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

NCT03576833 | Unknown FDA Device

• 1 other identifier: REK 2017/1574
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Adequate insertion

  percentage of adequate balloon insertion and balloon excretion

  4 months

Secondary Outcomes (1)

• weight loss

  4 months

Study Arms (1)

Balloon

EXPERIMENTAL

Device: Elipse Balloon system

Interventions

Elipse Balloon system DEVICE

intragastic balloon

Balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
• Previous bariatric or gastric surgery
• History of chronic or acute pancreatitis
• History of small bowel obstructions
• History of open abdominal and/or pelvic surgery EXCLUDING open appendectomy with a right lower quadrant incision.
• Thyroid or adrenal disease not controlled with medication
• 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
• Specific diagnosed genetic or hormonal cause for obesity such as Prader-Willi syndrome
• Severe coagulopathy, hepatic insufficiency or cirrhosis
• 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
• Anemia defined as either Hgb \<11 g/dL for females and \<12 g/dL for males
• Inability to walk 200 meters without assistance
• Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
• Current or history of illicit drug use or excessive alcohol use
• 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)

Sponsors & Collaborators

• Norwegian Department of Health and Social Affairs: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0318, Norway

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 3, 2018
• Study Start: May 15, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

NO (1)