Boomerang Early Feasibility Study

• Sponsor: Boomerang Medical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05414955
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 54

Study Details

Study Description

Brief Summary

Early feasibility study of neuromodulation in patients with IBD.

Condition or Disease	Intervention/Treatment	Phase
IBD	Device: Neuromodulation	N/A

Detailed Description

The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Boomerang Early Feasibility Study
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treated Patients implanted with neuromodulation	Device: Neuromodulation; Neuromodulation

Outcome Measures

Primary Outcome Measures

1. Disease Activity Index [up to 3 years]

   CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

General Inclusion Criteria:

• Male or female

• 18 to 85 years of age

• Disease duration of ≥ 6 months

• Ability and willingness to consent to participate by signing the informed consent form

• Ability to comply with the protocol and willingness to comply with all follow-up requirements

General Exclusion Criteria (The subject must not meet ANY of the following criteria):

• Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study

• Any psychiatric or personality disorder at the discretion of the study investigator

• History or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications

• Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)

• Active clostridium difficile infection of the colon

• Active cytomegalovirus (CMV) infection of the colon

• Evidence of colonic perforation

• Fulminant colitis requiring emergency surgery

• Microscopic, ischemic or infectious colitis

• Unresected neoplasia of the colon

• Presence of an ileostomy, colostomy, or enteral or parenteral feeding

• Colonic stricture unable to pass a colonoscope

• Active or latent tuberculosis

• History of cancer including melanoma (except for localized skin cancers) within 5 years

• Participation in another clinical trial within the past 30 days of device implant

• Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant

• Inability to operate the patient programmer

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boomerang Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boomerang Medical
• ClinicalTrials.gov Identifier: NCT05414955
• Other Study ID Numbers: Boomerang EFS
• First Posted: Jun 10, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 13, 2022