Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

HALO90 Ablation catheter

Device

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

Other names: Coagulation, Endoscopic Device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

Covidien, GI Solutions

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 14, 2010
Registry last updated: Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed