The Effect of Spatz3 Adjustable Balloon System Plus Diet and Exercise on Gastric Electrical Activity and Emptying
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-000124
Sponsor Protocol Number: 17-000124
About this study
The purpose of this study is to understand changes in gastric electrical activity and gastric emptying in response to the Spatz3 balloon and evaluate if baseline measurement of these gastric physiological changes can predict response to treatment, and to understand the impact that balloon volume adjustment after weight loss plateau has on gastric electrical activity and emptying and correlate these changes with effectiveness of the balloon volume adjustment in resulting in further weight loss after the balloon.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Spatz3 Adjustable Balloon System study IRB 15-008662
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Barham Abu Dayyeh, M.D., M.P.H. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available