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Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

18 Years
Not Enrolling
Pelvic Neoplasms

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Trial Information

Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

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.

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

3. Pregnancy and breastfeeding mothers

4. Subject is unable to provide informed consent for this study.

5. Pelvic irradiation within the last 6 months.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Jeffrey M. Marks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Case Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

June 2009

Related Keywords:

  • Pelvic Neoplasms
  • prostate cancer
  • endometrial cancer
  • radiation proctitis
  • pelvic radiotherapy
  • rectal bleeding
  • Neoplasms
  • Pelvic Neoplasms
  • Proctitis



University Hospitals Case Medical Center Cleveland, Ohio  44106