Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
This study is intended to prospectively gather information regarding the performance of an
endoscope-mounted radiofrequency (RF) energy device, which utilizes RF energy for the
coagulation of gastrointestinal tissue in the setting of bleeding of radiation proctitis.
The study device, the HALO90 Ablation catheter, has an FDA 510(k) clearance for human use.
The study design is a single-site, prospective clinical trial to gather performance data
regarding a 510(k)-cleared, endoscopically-guided radiofrequency energy ablation device for
the coagulation of hemorrhagic radiation proctitis.
Study subjects will have experienced bloody stools due to proctitis following pelvic
radiation for cancers of the prostate or uterine endometrium. The study will include female
and male adult patients who have received pelvic radiotherapy for such indications as cancer
of the prostate or endometrium and have subsequently experienced recurrent hemorrhagic
As part of this protocol, focal areas of the epithelial lining of the diseased colon,
rectum, and/or anus will be treated with the study device. The aim is to obtain information
about the hemostatic effect of this device. The treatment settings evaluated in this study
have been previously established with this device in the esophagus in "treat and resect"
protocols, as well as in clinical trials for Barrett's esophagus with long-term follow-up.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Adverse Events
As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.
Jeffrey M. Marks, MD
University Hospital Case Medical Center
United States: Institutional Review Board
|University Hospitals Case Medical Center||Cleveland, Ohio 44106|