Clinical trial · Interventional
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HALO90 Ablation catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ablation catheter
- description
- Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
- interventionNames
- Device: HALO90 Ablation catheter
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. History of pelvic irradiation. (Last radiation treatment must be greater than 6 months prior.) 2. Recurrent bloody stools. 3. Symptoms for \> 3 months. 4. No active infection or ulceration. 5. Diagnosis of radiation proctitis by endoscopic criteria. 6. Other sources of bloody stools, such as colon cancer, ulcerative colitis, or hemorrhoids, have been ruled out by prior colonoscopy. 7. Age ≥ 18 years old. 8. Subject is able to tolerate endoscopy and sedation. 9. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF). Exclusion Criteria: 1. History of anal incontinence, rectal resection or anorectal malignancy. 2. Presence of anorectal fistulae or stenoses preventing passage of the endoscope and device. 3. Pregnancy and breastfeeding mothers 4. Subject is unable to provide informed consent for this study. 5. Pelvic irradiation within the last 6 months.
References
Publications (0)
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