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Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

NCT01103492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-01-05

Study results available
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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

Interventions

DEVICE

HALO90 Ablation catheter

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

Sponsors & Collaborators

  • Covidien, GI Solutions

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey M. Marks, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103492 on ClinicalTrials.gov