Treatment of Hemorrhagic Radiation Proctitis Using the Halo System (NCT01103492) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
United States1 participantsStarted 2008-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. History of pelvic irradiation. (Last radiation treatment must be greater than 6 months prior.)
✓. Recurrent bloody stools.
✓. Symptoms for \> 3 months.
✓. No active infection or ulceration.
✓. Diagnosis of radiation proctitis by endoscopic criteria.
✓. Other sources of bloody stools, such as colon cancer, ulcerative colitis, or hemorrhoids, have been ruled out by prior colonoscopy.
✓. Age ≥ 18 years old.
✓. Subject is able to tolerate endoscopy and sedation.
Exclusion criteria
✕. History of anal incontinence, rectal resection or anorectal malignancy.
✕. Presence of anorectal fistulae or stenoses preventing passage of the endoscope and device.
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: 1 year
Trial details
NCT IDNCT01103492
SponsorUniversity Hospitals Cleveland Medical Center