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

NCT03576833 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-12

No results posted yet for this study

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

Interventions

DEVICE

Elipse Balloon system

intragastic balloon

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Norwegian Department of Health and Social Affairs

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2020-07-01
Completion
2020-12-31
FDA Device
Yes

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576833 on ClinicalTrials.gov