Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320395
Status:
WITHDRAWN
Last Update Posted:
2017-10-25
First Post:
2017-10-20
Brief Title:
Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation SB-RFA Catheter
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Treatment of Ex-vivo Small Bowel Mucosa With a Dedicated Radiofrequency Ablation SB-RFA Catheter
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal investigator left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastrointestinal angiodysplasia GIAD aka 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 Its 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
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 Its 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 aka 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 Its 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
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 Its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None