Barrett's EsophagusDOSENCT01845454
A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy
A study testing trūFreeze™ Spray Cryotherapy in people with Barrett's Esophagus, run by CSA Medical, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- trūFreeze™ Spray Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2013to Jan 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland, 21201
Ahuja/University Hospitals
Beachwood, Ohio, 44122
University of North Carolina, Chapel Hill
Chapel Hil, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Columbia University
New York, New York, 10032
About this study
Official title: A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy ("DOSE" Trial)
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.
Read the detailed description
This is an adaptive dose-escalation clinical trial using trūFreeze™ spray cryotherapy for the treatment of dysplastic Barrett's Esophagus in a clinical setting.
Participants will be enrolled in cohorts of up to 15. Each cohort will receive a similarly dosed spray cryotherapy treatment, based on outcomes from the previous cohort. Participants will receive one treatment with spray cryotherapy per the protocol and will then be followed clinically. During the next scheduled clinical endoscopy, participants will be assessed for percent regression of disease following the spray cryotherapy treatment. A determination will be made regarding effectiveness of each dose based on the number of subjects that achieve the primary outcome criterion (>= 50 percent BE segment regression).
The first cohort of up to 15 participants will receive an upper endoscopy in which systematic images of the esophagus will be taken for the research study and will then receive a treatment with spray cryotherapy using the trūFreeze™ system. These participants will have a clinical follow-up endoscopy scheduled approximately 2 months after the initial spray cryotherapy procedure. During the follow-up endoscopy, physicians will be asked to provide an estimate of the percent regression of disease as well as systematic images of the esophagus. These images will be sent to a central panel of masked experts who will assess percent regression of disease compared to images taken prior to the first ablation procedure.
Interim reviews of potential dose effectiveness will occur when 7 and 11 participants have completed the follow-up visit. If during an interim review at least 5 participants experience a sub-therapeutic response, the dose will be considered sub-therapeutic as not meeting the definition of "fully effective," the cohort will be closed to new enrollment, and enrollment on a new cohort at the next higher dose will begin. If during an interim review less than 5 participants experience a sub-therapeutic response, enrollment on that cohort will continue.
If/when enrollment on a cohort reaches 15 participants a decision will be made regarding the effectiveness of the dose. If a dose is found to be "ineffective" or "partially effective," then a new cohort of individuals will be enrolled at a prescribed higher starting dose. If a dose is found to be "fully effective," then a confirmatory cohort will be enrolled at the same dose to confirm results. Enrollment will continue until a "fully effective" therapeutic dose of spray cryotherapy is identified and confirmed in two cohorts of 15 participants each.
- Conditions
- Barrett's Esophagus
- Being tested
- trūFreeze™ Spray Cryotherapy
- Keywords
- Barrett's Esophagus, Spray cryotherapy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trūFreeze™ Spray CryotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: trūFreeze™ Spray Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)
Secondary outcomes (1)
Safety Outcomes
Secondary objectives are the determination of safety related outcomes such as esophageal stricture and will be captured by reportable events.
Measured: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionJan 2015
Why it stopped: poor enrollment and study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Shaheen, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845454
- Sponsor's protocol ID
- 006
- Acronym
- DOSE
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy ("DOSE" Trial)
- ClinicalTrials.gov ID
- NCT01845454
- Acronym / sponsor ID
- DOSE / 006
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Spray cryotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment and study design
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an adaptive dose-escalation clinical trial using trūFreeze™ spray cryotherapy for the treatment of dysplastic Barrett's Esophagus in a clinical setting.
Participants will be enrolled in cohorts of up to 15. Each cohort will receive a similarly dosed spray cryotherapy treatment, based on outcomes from the previous cohort. Participants will receive one treatment with spray cryotherapy per the protocol and will then be followed clinically. During the next scheduled clinical endoscopy, participants will be assessed for percent regression of disease following the spray cryotherapy treatment. A determination will be made regarding effectiveness of each dose based on the number of subjects that achieve the primary outcome criterion (>= 50 percent BE segment regression).
The first cohort of up to 15 participants will receive an upper endoscopy in which systematic images of the esophagus will be taken for the research study and will then receive a treatment with spray cryotherapy using the trūFreeze™ system. These participants will have a clinical follow-up endoscopy scheduled approximately 2 months after the initial spray cryotherapy procedure. During the follow-up endoscopy, physicians will be asked to provide an estimate of the percent regression of disease as well as systematic images of the esophagus. These images will be sent to a central panel of masked experts who will assess percent regression of disease compared to images taken prior to the first ablation procedure.
Interim reviews of potential dose effectiveness will occur when 7 and 11 participants have completed the follow-up visit. If during an interim review at least 5 participants experience a sub-therapeutic response, the dose will be considered sub-therapeutic as not meeting the definition of "fully effective," the cohort will be closed to new enrollment, and enrollment on a new cohort at the next higher dose will begin. If during an interim review less than 5 participants experience a sub-therapeutic response, enrollment on that cohort will continue.
If/when enrollment on a cohort reaches 15 participants a decision will be made regarding the effectiveness of the dose. If a dose is found to be "ineffective" or "partially effective," then a new cohort of individuals will be enrolled at a prescribed higher starting dose. If a dose is found to be "fully effective," then a confirmatory cohort will be enrolled at the same dose to confirm results. Enrollment will continue until a "fully effective" therapeutic dose of spray cryotherapy is identified and confirmed in two cohorts of 15 participants each.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Active comparator | Device: trūFreeze™ Spray CryotherapyThe 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. |
| Dose 2 | Active comparator | Device: trūFreeze™ Spray CryotherapyIf 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. |
| Dose 3 | Active comparator | Device: trūFreeze™ Spray CryotherapyIf 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. |
| Dose 4 | Active comparator | Device: trūFreeze™ Spray CryotherapyIf 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trūFreeze™ Spray CryotherapyThe 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. | Device | Dose 1, Dose 2, Dose 3, Dose 4 |
Primary outcome
Efficacy of Spray Cryotherapy Dose: Percent Regression of Disease Following Baseline Spray Cryotherapy
Time frame: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)
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
1 secondary outcome
Safety Outcomes
Time frame: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)
Results and safety
The study was stopped early (reason given: poor enrollment and study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Barrett's Esophagus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Shaheen, MD, MPH principal investigator
UNC Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trūFreeze™ Spray Cryotherapy in people with Barrett's Esophagus, run by CSA Medical, Inc. at 6 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 8 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: stopped early, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: poor enrollment and study design). Results are not available in the source record.
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?
Efficacy of Spray Cryotherapy Dose: Percent Regression of Disease Following Baseline Spray Cryotherapy (time frame: Next follow-up endoscopy scheduled as routine care (2 months +/- 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2016; AzTrials last refreshed its copy on 26 Oct 2026.