A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy

NCT01845454 | Terminated

• 1 other identifier: 006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.

Conditions

Barrett's Esophagus

Keywords

Barrett's Esophagus; Spray cryotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of Spray Cryotherapy Dose: Percent Regression of Disease Following Baseline Spray Cryotherapy

  Percent regression of disease will be used to determine efficacy of spray cryotherapy dose used. If at follow-up there is less than a 50% reduction in Barrett's Esophagus, the outcome will be characterized as sub-therapeutic for that participant. If a 50% or greater reduction is seen then this would be characterized as therapeutic. In each cohort of 15: * If less than 5 subjects are found to have a "therapeutic" response , dose = "ineffective" * If 5 to 10 subjects are found to have a "therapeutic" response, dose = "partially effective" * If 11 to 15 subjects have a "therapeutic" response, dose = "fully effective" If a dose is found to be "ineffective" or "partially effective", then a new evaluation cohort of 15 individuals will be enrolled on the next higher dose. If the dose is considered "fully effective" then a second cohort of 15 individuals will be enrolled on the same dose to confirm. Enrollment continues until a fully effective dose is attained and confirmed

  Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)

Secondary Outcomes (1)

• Safety Outcomes

  Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)

Study Arms (4)

Dose 1

ACTIVE COMPARATOR

The first 15 patients enrolled will receive a dose of 1 application of 20 seconds each of spray cryotherapy using the trūFreeze™ spray cryotherapy device throughout the affected tissue.

Device: trūFreeze™ Spray Cryotherapy

Dose 2

ACTIVE COMPARATOR

If a second cohort of 15 participants is necessary, the next dose will include 1 application of 30 seconds each of spray cryotherapy using the trūFreeze™ spray cryotherapy device throughout the affected tissue.

Device: trūFreeze™ Spray Cryotherapy

Dose 3

ACTIVE COMPARATOR

If an additional cohort of 15 participants is necessary, the next dose will include 2 applications of 20 seconds each of spray cryotherapy using the trūFreeze™ spray cryotherapy device throughout the affected tissue.

Device: trūFreeze™ Spray Cryotherapy

Dose 4

ACTIVE COMPARATOR

If an additional cohort of 15 participants is necessary, the next dose will include 2 applications of 30 seconds each of spray cryotherapy using the trūFreeze™ spray cryotherapy device throughout the affected tissue.

Device: trūFreeze™ Spray Cryotherapy

Interventions

trūFreeze™ Spray Cryotherapy DEVICE

The trūFreeze™ System consists of a console containing a holding tank for medical grade liquid nitrogen and a spray tip CSATM Catheter. The physician uses the console to initiate and control the flow and duration of the cryogen spray. The liquid nitrogen is propelled through a spray CSATM Catheter to the selected site by pressure in the holding tank and freezing techniques are monitored by direct visualization with an endoscope. Once the freezing is completed, the cryogen flow is terminated and the thawing system may be engaged to allow accessory removal. If multiple cycles are used, thawing is initiated at the end of the procedure.

Dose 1; Dose 2; Dose 3; Dose 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking males or females aged 18 to 80 who are candidates for sedated endoscopy with treatment of BE.
• At least 3 centimeters segment length of Barrett's Esophagus (BE) with or without circumferential involvement (i.e. CxM3) and with high grade or low grade dysplasia based on pathology results from 4 quadrant biopsies taken every 1-2 centimeter throughout the BE. All readings of dysplasia will be confirmed by an expert pathologist.
• Willing to undergo spray cryotherapy and judged by patient's physician as an appropriate candidate for this therapy.
• Able to read, comprehend, and complete the informed consent form

You may not qualify if:

• Bleeding disorder or other contraindication of spray cryotherapy.
• History of partial or complete esophagectomy.
• Current or past diagnosis of invasive esophageal cancer (previous intramucosal cancer is allowable, if removed by endoscopic mucosal resection with histologically confirmed negative lateral and deep margins).
• Pregnant women
• Contraindication to endoscopic spray cryotherapy as outlined in the directions for use for the device
• Previous endoscopic ablation treatment (such as radiofrequency ablation (RFA) or photodynamic therapy (PDT)).
• Previous chest external beam radiation therapy.
• Previous wide-area endoscopic resection or submucosal dissection. Previous focal mucosal resection is permitted (maximum 2 previous EMR's of 2cm or less removed representing less than 25% of the circumference of the esophagus removed).

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (6)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina, Chapel Hill

Chapel Hil, North Carolina, 27599, United States

Location

Ahuja/University Hospitals

Beachwood, Ohio, 44122, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)