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Procedure

Cryotherapy for Esophageal Cancer

N/A
Waitlist Available
Led By Nicholas Shaheen, MD
Research Sponsored by US Endoscopy Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has persistent esophageal cancer with local luminal involvement and who is not a surgical candidate or has completed or declined systemic therapy
Subject is able to tolerate endoscopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post sct procedure
Awards & highlights

Study Summary

This trial will study the effects of a cryotherapy system on people with esophageal cancer who can't have surgery or have finished or declined systemic therapy.

Who is the study for?
This trial is for adults aged 18-89 with persistent esophageal cancer who can't have surgery or have chosen not to continue systemic therapy. Participants must be able to undergo endoscopy and provide informed consent. Pregnant individuals, recent recipients of certain cancer treatments, or those with an esophageal stent cannot join.Check my eligibility
What is being tested?
The study is examining the effects of trūFreeze® Spray Cryotherapy System on patients with local esophageal cancer who are not candidates for surgery. It's a prospective, open-label study without a control group, conducted across multiple centers.See study design
What are the potential side effects?
While specific side effects are not listed here, spray cryotherapy may include risks such as pain at the treatment site, swelling, infection risk from endoscopy procedure and potential complications related to cold temperature exposure in body tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My esophageal cancer is still present, I can't have surgery, and I've finished or declined other treatments.
Select...
I can undergo an endoscopy procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post sct procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post sct procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline EORTC at 14 days post cryotherapy procedure
Change from baseline dysphagia scale at 14 days post cryotherapy procedure
Secondary outcome measures
Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session
Overall Survival
Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)

Trial Design

1Treatment groups
Experimental Treatment
Group I: trūFreeze® System spray cryotherapyExperimental Treatment1 Intervention
trūFreeze® System spray cryotherapy as clinically indicated for symptom relief

Find a Location

Who is running the clinical trial?

US Endoscopy Group Inc.Lead Sponsor
2 Previous Clinical Trials
287 Total Patients Enrolled
Nicholas Shaheen, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
275 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants younger than twenty-five years old taking part in this experiment?

"This clinical trial is open to all individuals aged 18-89. Other trials, targeted at minors and those over 65 respectively, offer opportunities for 10 and 378 patients."

Answered by AI

Who is eligible to participate in this trial?

"This study aims to enroll 51 individuals with esophageal cancer aged 18-89. Applicants must meet the following criteria: possessing persistent esophageal cancer localized to a lumen, able to endure endoscopic procedures, and be male or female between 18-89 years of age. Additionally, prospective participants should have declined or completed systemic therapies prior to enrollment."

Answered by AI

Are there any openings for individuals to participate in this trial?

"According to clinicaltrials.gov, this study is not presently open for recruitment as the last edit was made on July 22nd 2022. Nonetheless, 379 other medical trials are now looking for prospective candidates at present."

Answered by AI

In which geographic regions is this trial being conducted?

"10 medical centres are partaking in this trial, including Dartmouth-Hotchcock Medical Center situated in Lebanon, Parkview Comprehensive Cancer Centre located in Fort Wayne and the Cancer Treatment Centers of America Western Regional Medical Centre based in Goodyear. There are 7 other sites involved as well."

Answered by AI
~7 spots leftby Mar 2025