Pelvic Neoplasms Clinical Trial
Official title:
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
This study involves evaluating a procedure in which the study device, the HALO90 Ablation
catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF)
energy in subjects suffering from radiation proctitis (acute inflammation of the inner
lining of the rectum caused by the side effects of radiation treatments that can lead to
bleeding).
In medical procedures, the RF energy used with this device, has been historically used in
shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The
device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit
with stoping bleeding and clotting of blood) of tissue within the digestive tract. The
device has been used in areas outside the esophagus (inner lining of the throat), including
the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis,
using the HALO device, may be one method to control the bleeding.
The purpose of this study is to evaluate the effectiveness and record the results of
treatment of radiation proctitis using the HALO device.
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
radiation proctitis.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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