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Esophageal CancerNCT03243734

trūFreeze® Palliative Esophageal Cancer

A study testing trūFreeze® System spray cryotherapy in people with Esophageal Cancer, run by US Endoscopy Group Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Esophageal Cancer
What is being tested?
trūFreeze® System spray cryotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
10 sitesUnited States
Study dates
6 Nov 2017to 6 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Parkview Comprehensive Cancer Center

    Fort Wayne, Indiana, 46845

  • Cancer Treatment Centers of America Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Spectrum Health

    Grand Rapids, Michigan, 49546

  • Dartmouth-Hotchcock Medical Center

    Lebanon, New Hampshire, 03756

  • North Shore-Long Island Jewish Medical Center

    Manhasset, New York, 11030

  • University of California at Irvine

    Orange, California, 92868

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
trūFreeze® System spray cryotherapy
Keywords
spray cryotherapy, quality of life, symptom reduction, esophageal malignancies, liquid nitrogen, ablation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trūFreeze® System spray cryotherapyDevice

    Subjects where trūFreeze® System spray cryotherapy is performed

Study groups in NCT03243734
Study groupRoleWhat they receive
trūFreeze® System spray cryotherapyExperimentaltrūFreeze® System spray cryotherapy as clinically indicated for symptom relief
Receives: Device: trūFreeze® System spray cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline EORTC at 14 days post cryotherapy procedure

    Validated Cancer Specific Quality of Life Questionnaire

    Measured: 14 days post spray cryotherapy

  2. Change from baseline dysphagia scale at 14 days post cryotherapy procedure

    Dysphagia Severity Scale

    Measured: 14 days post spray cryotherapy

Secondary outcomes (3)

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

    baseline to procedure other than spray cryotherapy

    Measured: up to 2 years post SCT procedure

  2. Overall Survival

    SCT to death

    Measured: up to 2 years post SCT procedure

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

    Describe changes in tumor

    Measured: up to 2 years post SCT procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start6 Nov 2017
  3. Primary completion13 Jul 2022
  4. Study completion6 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243734
Sponsor's protocol ID
017
Status last verified
Sep 2023
First submitted
3 Aug 2017
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing trūFreeze® System spray cryotherapy in people with Esophageal Cancer, run by US Endoscopy Group Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline EORTC at 14 days post cryotherapy procedure (time frame: 14 days post spray cryotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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