trūFreeze® Palliative Esophageal Cancer

May 7, 2024 updated by: US Endoscopy Group Inc.

A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular water being frozen in place such that ice crystals are formed. These ice crystals aggregate quickly causing immediate intracellular energy producing organelles to be destroyed leading to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs with a subsequent debulking of the tumor mass. Normal tissue will regenerate as re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a "hard freeze" leads to more extensive primary cell death over a shorter freeze time as compared to cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce symptoms of dysphagia, delay the time until stent is needed, provide palliative care for patients for whom additional tri-modal therapies are not an option, and may increase quality of life in esophageal cancer patients. The studies conducted to date have provided documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for malignancies in the esophagus. Measures of dysphagia relief have been described in peer reviewed literature. This study aims to provide much needed HRQOL information as well as additional tumor characteristics before and after SCT. A cohort of patients with locally persistent esophageal cancer will be studied in up to twelve (12) centers in the United States to provide important HRQOL data and more a comprehensive understanding of clinical tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy procedure will be performed during endoscopy. Each SCT procedure will be performed endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure dosimetry will be delivered at the discretion of the Investigator based on tumor location and patient tolerability. After each procedure at defined intervals, patients will be contacted and QOL symptom related information will be collected. If at any point an Investigator determines that a subject is not a candidate for further spray cryotherapy or is unable to tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL information. Subject participation will last up to two years or until death

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Cancer Treatment Centers of America Western Regional Medical Center
    • California
      • Orange, California, United States, 92868
        • University of California at Irvine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Comprehensive Cancer Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hotchcock Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore-Long Island Jewish Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: trūFreeze® System spray cryotherapy
trūFreeze® System spray cryotherapy as clinically indicated for symptom relief
Device: trūFreeze® System spray cryotherapy
Subjects where trūFreeze® System spray cryotherapy is performed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline EORTC at 14 days post cryotherapy procedure
Time Frame: 14 days post spray cryotherapy
Validated Cancer Specific Quality of Life Questionnaire
14 days post spray cryotherapy
Change from baseline dysphagia scale at 14 days post cryotherapy procedure
Time Frame: 14 days post spray cryotherapy
Dysphagia Severity Scale
14 days post spray cryotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)
Time Frame: up to 2 years post SCT procedure
baseline to procedure other than spray cryotherapy
up to 2 years post SCT procedure
Overall Survival
Time Frame: up to 2 years post SCT procedure
SCT to death
up to 2 years post SCT procedure
Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session
Time Frame: up to 2 years post SCT procedure
Describe changes in tumor
up to 2 years post SCT procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Endoscopy Group Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas Shaheen, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 017 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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