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Barrett EsophagusColdPlayIIINCT02514525

Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System

A study testing CryoBalloon Ablation System in people with Barrett Esophagus, run by Pentax Medical at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Barrett Esophagus
What is being tested?
CryoBalloon Ablation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
11 sitesUnited States
Study dates
Mar 2016to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
  • BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
  • Older than 18 years of age at time of consent
  • Operable per institution's standards
  • Provides written informed consent on the approved informed consent form
  • Willing and able to comply with study requirements for follow-up

Who cannot join

  • Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
  • Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
  • Symptomatic untreated strictures
  • Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
  • History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
  • History of esophageal varices
Show all 16Show fewer
  • Large (>4cm) hiatal hernia
  • Prior distal esophagectomy
  • Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
  • Active esophagitis grade B or higher
  • Severe medical comorbidities precluding endoscopy
  • Uncontrolled coagulopathy
  • Pregnant or planning to become pregnant during period of study participation
  • Patient refuses or is unable to provide written informed consent
  • Life expectancy ≤3 years, as judged by the site investigator
  • General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • John Hopkins

    Baltimore, Maryland, 21205

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Northwell Health

    Manhasset, New York, 11030

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032

  • UC Irvine

    Orange, California, 92868

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

Other trials in United States

About this study

Official title: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Read the detailed description

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

Being tested
CryoBalloon Ablation System
Medical subject headings
Barrett Esophagus

What participants receive

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

  • CryoBalloon Ablation SystemDevice

    Also called CryoBalloon Focal Ablation System

    CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.

Study groups in NCT02514525
Study groupRoleWhat they receive
CryoBalloon Ablation SystemOtherCryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Receives: Device: CryoBalloon Ablation System

What is being measured

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

  1. Incidence of serious, CryoBalloon Ablation System-related adverse events

    Measured: 12 months

  2. Percentage of patients with baseline LGD who have complete eradication of all dysplasia

    Measured: 12 months

  3. percentage of patients with baseline HGD who have complete eradication of all dysplasia

    Measured: 12 months

  4. percentage of all treated patients who have complete eradication of all dysplasia (CE-D)

    Measured: 12 months

Secondary outcomes (9)

  1. Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM)

    Measured: 12 months

  2. Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer

    For Baseline LGD and HGD subjects: progression of dysplasia

    Measured: 12 months

  3. Incidence of all treatment-related and all serious, non-treatment-related adverse events

    Measured: 12 months

  4. Incidence of post procedure chest discomfort events / Pain score >0 and <5

    (scored on a 0-10 visual analog pain scale)

    Measured: Day 1

  5. Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic

    (scored on a 0-10 visual analog pain scale)

    Measured: Day 7

  6. Mean and Median Pain score on Day 1 post procedure

    (scored on a 0-10 visual analog pain scale)

    Measured: Day 1

  7. Mean and Median Pain score on Day 7 post procedure

    (scored on a 0-10 visual analog pain scale)

    Measured: Day 7

  8. Rate of (CE-D) and all esophageal (CE-IM) will be reported as a percentage of all subjects enrolled, and stratified by baseline dysplasia grade

    Measured: 24 and 36 months

  9. Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM

    (mean and median)

    Measured: 12 months

Timeline

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

  1. First posted3 Aug 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2024
  4. Study completionDec 2025 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02514525
Sponsor's protocol ID
CP-0011
Acronym
ColdPlayIII
Status last verified
Jan 2025
First submitted
31 Jul 2015
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual participant data will not be shared.

Publications

  • Canto MI, Trindade AJ, Chak A, Dumot JA, Iyer PG, Khara HS, Diehl DL, Corbett FS, Shin EJ, McKinley M, Waxman I, Infantolino A, Tofani CJ, Chang KJ, Lightdale CJ, Goldblum JR, Voltaggio L, Montgomery EA, Abrams JA, Shaheen NJ. Durability of cryoballoon ablation for eradication of neoplastic Barrett's esophagus: a multicenter prospective cohort study (with video). Gastrointest Endosc. 2026 Jun;103(6):1153-1162.e1. doi: 10.1016/j.gie.2025.11.030. Epub 2025 Nov 21.

    PubMed 41275893

  • Canto MI, Trindade AJ, Abrams J, Rosenblum M, Dumot J, Chak A, Iyer P, Diehl D, Khara HS, Corbett FS, McKinley M, Shin EJ, Waxman I, Infantolino A, Tofani C, Samarasena J, Chang K, Wang B, Goldblum J, Voltaggio L, Montgomery E, Lightdale CJ, Shaheen NJ. Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial. Am J Gastroenterol. 2020 Nov;115(11):1879-1890. doi: 10.14309/ajg.0000000000000822.

    PubMed 33156107

Questions about this trial

What is this clinical trial studying?

A study testing CryoBalloon Ablation System in people with Barrett Esophagus, run by Pentax Medical at 11 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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of serious, CryoBalloon Ablation System-related adverse events (time frame: 12 months). The study lists 4 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 NCT02514525, which also lists 2 linked publications.

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 13 Jan 2025.

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