NCT03243734

Brief Summary

Prospective, open label, non-controlled single arm, multi-center study The primary objective is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

May 8, 2024

Status Verified

September 1, 2023

Enrollment Period

4.7 years

First QC Date

August 3, 2017

Last Update Submit

May 7, 2024

Conditions

Esophageal Cancer

Keywords

spray cryotherapyquality of lifesymptom reductionesophageal malignanciesliquid nitrogenablation

Outcome Measures

Primary Outcomes (2)

  • Change from baseline EORTC at 14 days post cryotherapy procedure

    Validated Cancer Specific Quality of Life Questionnaire

    14 days post spray cryotherapy

  • Change from baseline dysphagia scale at 14 days post cryotherapy procedure

    Dysphagia Severity Scale

    14 days post spray cryotherapy

Secondary Outcomes (3)

  • Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)

    up to 2 years post SCT procedure

  • Overall Survival

    up to 2 years post SCT procedure

  • Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session

    up to 2 years post SCT procedure

Study Arms (1)

trūFreeze® System spray cryotherapy

EXPERIMENTAL

trūFreeze® System spray cryotherapy as clinically indicated for symptom relief

Device: trūFreeze® System spray cryotherapy

Interventions

trūFreeze® System spray cryotherapyDEVICE

Subjects where trūFreeze® System spray cryotherapy is performed

trūFreeze® System spray cryotherapy

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females of 18 to 89 years of age.
  • Subject is able to read, understand, and sign a written Informed Consent to participate in the study.
  • 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

You may not qualify if:

  • Subject is pregnant, nursing, or planning to get pregnant during study duration.
  • Subjects with an esophageal stent in situ at the time of study enrollment
  • Subject, as deemed by treating investigator has contraindication to endoscopy or Spray Cryotherapy Procedure.
  • Subject has received radiation within the past 6 weeks
  • Subject has received chemotherapy within the past 2 weeks Subject has received immunotherapy within 30 days
  • Subject has participated in another clinical study for systemic therapy within 6 weeks of baseline.
  • Subject has had previous Spray Cryotherapy for esophageal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

University of California at Irvine

Orange, California, 92868, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Parkview Comprehensive Cancer Center

Fort Wayne, Indiana, 46845, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49546, United States

Location

Dartmouth-Hotchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

North Shore-Long Island Jewish Medical Center

Manhasset, New York, 11030, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Nicholas Shaheen, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 9, 2017

Study Start

November 6, 2017

Primary Completion

July 13, 2022

Study Completion

March 6, 2024

Last Updated

May 8, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(10)