Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103492
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : April 27, 2011
Last Update Posted : January 5, 2015
Covidien, GI Solutions
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Neoplasms Device: HALO90 Ablation catheter Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: Ablation catheter
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.
Device: HALO90 Ablation catheter
FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.
Other Names:
  • Coagulation
  • Endoscopic Device

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 1 year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103492

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Covidien, GI Solutions
Principal Investigator: Jeffrey M. Marks, MD University Hospitals Cleveland Medical Center

Responsible Party: Jeffrey Marks, MD, Principal Investigator, University Hospitals Cleveland Medical Center Identifier: NCT01103492     History of Changes
Other Study ID Numbers: 11-07-46
First Posted: April 14, 2010    Key Record Dates
Results First Posted: April 27, 2011
Last Update Posted: January 5, 2015
Last Verified: December 2014

Keywords provided by Jeffrey Marks, MD, University Hospitals Cleveland Medical Center:
prostate cancer
endometrial cancer
radiation proctitis
pelvic radiotherapy
rectal bleeding

Additional relevant MeSH terms:
Pelvic Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Neoplasms by Site