Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation (SB-RFA) Catheter.
Primary Purpose
Angiodysplasia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Small bowel RFA treatment
Sponsored by
About this trial
This is an interventional treatment trial for Angiodysplasia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability to provide informed consent.
- Inability to isolate disease free section of small bowel or sufficient small bowel to perform SB-RFA treatment..
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Small bowel RFA treatment
Arm Description
Five small bowel samples each of the duodenum, jejunum and ileum will be recruited treated.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03320395
First Posted
October 20, 2017
Last Updated
October 20, 2017
Sponsor
The Cleveland Clinic
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03320395
Brief Title
Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation (SB-RFA) Catheter.
Official Title
Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation (SB-RFA) Catheter.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator left the institution.
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Gastrointestinal angiodysplasia (GIAD, a.k.a. angioectasia, arteriovenous malformations or AVM, and vascular ectasia) are mucosal or submucosal dilated blood vessels lined by epithelium with no overlying mucosal lesion formed due to a combination of sub-mucosal vein obstruction, hypoxemia and neovascularization. It is a frequent cause of obscure GI bleeding, and the most common finding when evaluating mid-small bowel hemorrhage. It is also more common in patients with underlying valvular heart disease (especially aortic stenosis), end-stage renal disease, and von Willebrand disease (acquired or congenital). These lesions are usually multifocal as forty to 60% of the patients will have more than one About half stop bleeding spontaneously but at least a quarter of patients will suffer recurrent GI bleeding manifested by overt bleeding (melena or hematochezia), persistent fecal occult blood or persistent iron deficiency anemia.
Management includes endoscopic therapy, surgery, therapeutic angiography, and pharmacological treatment. Endoscopic therapy including thermal methods (multi-polar electrocoagulation, argon plasma coagulation, laser), injections (sclerosants, saline, epinephrine), and mechanical methods (hemostatic clips, band ligators) are widely used to treat all causes of GI bleeding including GIAD. Argon plasma coagulation (APC) is the preferred mode of endoscopic therapy for GIAD due to availability, relative ease of use, and a perceived superficial rather than deep depth of burn; however, studies have shown that depth of tissue injury can be substantial. APC therapy may not be uniform as adequacy and depth of ablation depends on the presence of debris, mucous or blood between the APC probe and tissue, and the ability to target the tissue in the presence of breathing, intestinal peristalsis, and scope position. The APC catheter can also bend during repeated insertions, a necessary maneuver to remove the burned tissue debris on the tip of the catheter which otherwise affects the argon plasma beam and this may terminally damage it.
Angioectasia rebleeding rates are high, at least 25 to over 50%. An improvement in our ability to treat small bowel GIAD 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 while treating GIAD.
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.
This study will determine the depth of burn achieved on fresh and healthy small bowel explants using a dedicated small bowel RFA catheter at usual RFA settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiodysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small bowel RFA treatment
Arm Type
Experimental
Arm Description
Five small bowel samples each of the duodenum, jejunum and ileum will be recruited treated.
Intervention Type
Device
Intervention Name(s)
Small bowel RFA treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depth of small bowel mucosa treatment
Description
Study of the effect of RFA treatment on ex-vivo healthy small bowel mucosa including duodenum, jejunum, and ileum.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Inability to provide informed consent.
Inability to isolate disease free section of small bowel or sufficient small bowel to perform SB-RFA treatment..
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation (SB-RFA) Catheter.
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