Trial Outcomes & Findings for Treatment of Hemorrhagic Radiation Proctitis Using the Halo System (NCT NCT01103492)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

1 year

Results posted on

2015-01-05

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Treatment of Hemorrhagic Radiation Proctitis Using the Halo System

Baseline characteristics by cohort
Measure	Ablation Catheter n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	77 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

Timeframe: 1 year

Population: There was no analysis of the data. Feasibility study with only one subject enrolled

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.

Outcome measures
Measure	Ablation Treatment n=1 Participants Subjects with radiation proctitis who met inclusion criteria
Number of Participants With Adverse Events	0 partipants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Ablation Catheter n=1 participants at risk 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.
Gastrointestinal disorders Rectal Bleeding	100.0% 1/1 • Number of events 1

Adverse event data not reported

University Hospitals Case Medical Center

Phone: 216-983-4930