N/A
N=1
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
Pelvic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01103492 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Adverse Events — 0 partipants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HALO90 Ablation catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
— | — |
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.
Eligibility Criteria
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.
- Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01103492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.