Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

This study has been completed.
Sponsor:
Collaborator:
Covidien, GI Solutions
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01103492
First received: April 13, 2010
Last updated: June 16, 2012
Last verified: June 2012
  Purpose

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 Intervention
Pelvic Neoplasms
Device: HALO90 Ablation catheter

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103492

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

No publications provided

Responsible Party: Jeffrey Marks, MD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01103492     History of Changes
Other Study ID Numbers: 11-07-46
Study First Received: April 13, 2010
Results First Received: March 29, 2011
Last Updated: June 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
prostate cancer
endometrial cancer
radiation proctitis
pelvic radiotherapy
rectal bleeding

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

ClinicalTrials.gov processed this record on July 26, 2014