Bariatric Embolization Procedure for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+2 MoreBariatric Embolization of Arteries with imaging visible Embolics - Device
Eligibility
21 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that transvascular bariatric embolization resulted in safe and effective weight loss in obese participants compared to control subjects.

Eligible Conditions
  • Obesity
  • Weight Loss
  • Morbid Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Efficacy of Bariatric Embolization procedure: Change in body weight

Trial Safety

Trial Design

2 Treatment Groups

Bariatric Embolization Procedure
1 of 2
Control Arm
1 of 2

Active Control

Non-Treatment Group

59 Total Participants · 2 Treatment Groups

Primary Treatment: Bariatric Embolization Procedure · Has Placebo Group · N/A

Control Arm
Other
ShamComparator Group · 1 Intervention: Control Arm · Intervention Types: Other
Bariatric Embolization Procedure
Device
ActiveComparator Group · 1 Intervention: Bariatric Embolization of Arteries with imaging visible Embolics · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,569 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,166 Total Patients Enrolled
41 Trials studying Obesity
6,932 Patients Enrolled for Obesity
Clifford Weiss, M.D.Principal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 21 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female, aged ≥21 and ≤70 years.
You are willing, able, and mentally competent to provide written informed consent.
You are of reproductive potential.
You have participated in the study for at least 6 months.
You are living or working within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs.
Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography.
You have failed conservative weight loss therapy and are 18 or older.

Who else is applying?

What state do they live in?
North Carolina14.3%
Virginia14.3%
Maryland14.3%
Other57.1%
How old are they?
18 - 65100.0%
What site did they apply to?
Johns Hopkins University100.0%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%
Why did patients apply to this trial?
  • "I've tried several dieting programs and they only work for a short time."
How many prior treatments have patients received?
0100.0%
References