Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
Completed · Not applicable
Conditions studied: Pelvic Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01103492
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 1
- Starts
- 2008-07-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2015-01-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF).
You may not qualify if…
- History of anal incontinence, rectal resection or anorectal malignancy.
- Presence of anorectal fistulae or stenoses preventing passage of the endoscope and device.
- Pregnancy and breastfeeding mothers
- Subject is unable to provide informed consent for this study.
- Pelvic irradiation within the last 6 months.
Where it is running
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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