Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation (SB-RFA) Catheter.

NCT03320395 | Withdrawn

• 1 other identifier: FLA 16-032
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastrointestinal angiodysplasia (GIAD, a.k.a. angioectasia, arteriovenous malformations or AVM, and vascular ectasia) are mucosal or submucosal dilated blood vessels, usually multifocal, and a frequent cause of obscure GI bleeding, especially mid-small bowel hemorrhage. Endoscopic treatment using argon plasma coagulation (APC) is popular but presents limitations as application of the therapy is not uniform, and passing the catheter repetitively through the enteroscope may not be possible. Despite endoscopic treatment rebleeding rates are high, between 25 to 50%. An improvement in our ability to treat GIAD endoscopically is desirable. An ablation catheter would need to be easy to use repetitively through the enteroscope, be more maneuverable to direct treatment to the lesions, and also cover more area of intestinal mucosa per treatment compared to APC, and it should be low risk for damage to the healthy intestinal mucosa. Radiofrequency ablation (RFA) may hold the answer. It's efficacy for treatment of superficial Barrett esophagus is undisputed, and it has recently been used with success to treat gastric antral vascular ectasia (GAVE) a condition which is remarkably similar to GIAD.

Conditions

Angiodysplasia

Outcome Measures

Primary Outcomes (1)

• Depth of small bowel mucosa treatment

  Study of the effect of RFA treatment on ex-vivo healthy small bowel mucosa including duodenum, jejunum, and ileum.

  3 months

Study Arms (1)

Small bowel RFA treatment

EXPERIMENTAL

Five small bowel samples each of the duodenum, jejunum and ileum will be recruited treated.

Device: Small bowel RFA treatment

Interventions

Small bowel RFA treatment DEVICE

The samples will be spread and fixed using needles. The prototype RFA-SB ablation catheter will be applied by the PI as follows to each section of duodenum, jejunum and ileum. The treating paddle of the prototype RFA-SB catheter will be pushed on the small bowel mucosa exerting the same pressure that would be applied endoscopically. 12 J/cm2 will be applied every time with a 20 second interval between applications to simulate clinical practice. There will be two single applications to two separate specimen sites. There will be two double applications to two separate specimen sites. There will be two triple applications to two separate specimen sites. There will be two quadruple applications to two separate specimen sites.

Small bowel RFA treatment

Eligibility Criteria

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

You may qualify if:

• Understand and provide informed consent.
• All patients must be over 18 years of age, otherwise no age restrictions.
• Healthy small bowel tissue has cleared by pathology as tissue that would otherwise be discarded.
• Patients who are undergoing planned resection of the small bowel will be recruited until the study endpoints are met.

You may not qualify if:

• Inability to provide informed consent.
• Inability to isolate disease free section of small bowel or sufficient small bowel to perform SB-RFA treatment..

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Angiodysplasia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share