Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

NCT01103492 | Completed Results

• 1 other identifier: 11-07-46
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Neoplasms

Keywords

prostate cancer; endometrial cancer; radiation proctitis; pelvic radiotherapy; rectal bleeding

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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.

  1 year

Study Arms (1)

Ablation catheter

EXPERIMENTAL

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

Interventions

HALO90 Ablation catheter DEVICE

FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.

Also known as: Coagulation, Endoscopic Device

Ablation catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Covidien, GI Solutions: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pelvic Neoplasms; Prostatic Neoplasms; Endometrial Neoplasms; Gastrointestinal Hemorrhage

Interventions

Blood Coagulation Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Jeffrey Marks, MD
• Organization: University Hospitals Case Medical Center

Jeffrey.Marks@uhhospitals.org

216-983-4930

Study Officials

• Jeffrey M. Marks, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 14, 2010
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 5, 2015
• Results First Posted: April 27, 2011

Record last verified: 2014-12

Locations

US (1)