Barrett EsophagusNCT03311451
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
A study testing C2 CryoBalloon 180° Ablation System in people with Barrett Esophagus, run by Merit Medical Systems, Inc. at 6 sites in Netherlands.
Trial summary
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma. 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?
- C2 CryoBalloon 180° Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesNetherlands
- Study dates
- 16 Jan 2023to 18 Dec 2026
- 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
- Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
- Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR
- Residual BE with any grade of dysplasia 6 weeks after endoscopic resection
- Prague Classification Score C≤3 and ≥M1
- Patients should be ablation-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
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- Operable per institution's standards
- Patient provides written informed consent on the IRB-approved informed consent form
- Patient is willing and able to comply with follow-up requirements.
Who cannot join
- Esophageal stenosis preventing advancement of a therapeutic endoscope
- Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol.
- Prior ER of more than 2cm in length and/or >50% of the esophageal lumen circumference
- History of locally advanced (>SM1) esophageal cancer
- History of esophageal varices
- Prior distal esophagectomy
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- Active esophagitis LA grade B or higher
- Severe medical comorbidities precluding endoscopy
- Uncontrolled coagulopathy
- Pregnant or planning to become pregnant during period of study
- Patient refuses or is unable to provide written informed consent
- Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study
- General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
AMC Medical Research B.V.
Amsterdam, Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands
UMC Groningen
Groningen, Netherlands
St. Antonius Hospital
Nieuwegein
Erasmus Medical Center
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
About this study
Official title: Clinical Trial To Evaluate Safety and Efficacy of the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
Read the detailed description
The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 62 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference.
All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues.
If follow-up shows that Dose 1 eradicates ≤60% of the treated BE (by median percentage) and no SAE's are reported, the treatment phase will continue but at the next incremental higher dose (Second Dose) after approval from the IRB.
If the Dose 1 median BE surface regression percentage is ≥60%, the dose is defined as the therapeutic dose. In that case, the study will be prematurely terminated without the consecutive treatment of an additional 62 patients with a higher dose.
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Dose-related SAEs include pain in the treatment area greater than 6 (0-10 NRS score) at 24 hours AND seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the therapeutic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
- Conditions
- Barrett Esophagus
- Being tested
- C2 CryoBalloon 180° 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.
C2 CryoBalloon 180° Ablation SystemDevice
Also called CryoBalloon 180
The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.
| Study group | Role | What they receive |
|---|---|---|
| C2 CryoBalloon 180 Ablation System | Other | C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus Receives: Device: C2 CryoBalloon 180° Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Dose response
Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Measured: 10 weeks
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of Dose-related SAEs.
Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Measured: 30 days
Secondary outcomes (5)
Incidence of AEs
Incidence of all serious and non-serious adverse events up to 30 days post-treatment
Measured: 30 days
Patient reported post-procedure pain
Post-procedure pain in the area of the cryoablation treatment (0-10 NRS score)
Measured: 24hours, 7 days and 30 days post-procedure
Efficacy: Percent Regression
Efficacy, defined as the regression percentage at the first follow-up endoscopy, after one (1) treatment covering 50% of circumference of the esophagus with the therapeutic dose.
Measured: 10 weeks
Efficacy: Treatment
Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 hemi-circumferential and after full circumferential treatment.
Measured: 10 weeks
Post procedure dysphagia score
Post procedure dysphagia score (scored 0-4 dysphagia score), described as median dysphagia score directly
Measured: 24 hours, 7 days and 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start16 Jan 2023
- Primary completion18 Jun 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3 and ≥M1) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after endoscopic resection of dysplasia or early adenocarcinoma. During the treatment phase, two doses will be tested consecutively starting with the lowest dose (1.2mm/sec). For each dose a total of 62 patients will be included. An interim analysis will be performed after treatment of the first 62 patients with lowest dose, before proceeding to treatment of additional 62 patients with a higher dose of 1.1mm/sec.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bas LA Weusten, MD, PhD, Principal investigator, St. Antonius Ziekenhuis, Niewegein The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311451
- Sponsor's protocol ID
- CP-0019
- Status last verified
- May 2026
- First submitted
- 10 Oct 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial To Evaluate Safety and Efficacy of the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
- ClinicalTrials.gov ID
- NCT03311451
- Acronym / sponsor ID
- CP-0019
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 18 Jun 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 17 Oct 2017 (actual)
- 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 is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
Detailed description
The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 62 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference.
All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues.
If follow-up shows that Dose 1 eradicates ≤60% of the treated BE (by median percentage) and no SAE's are reported, the treatment phase will continue but at the next incremental higher dose (Second Dose) after approval from the IRB.
If the Dose 1 median BE surface regression percentage is ≥60%, the dose is defined as the therapeutic dose. In that case, the study will be prematurely terminated without the consecutive treatment of an additional 62 patients with a higher dose.
---------------------------------------------------------------
Dose-related SAEs include pain in the treatment area greater than 6 (0-10 NRS score) at 24 hours AND seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the therapeutic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3 and ≥M1) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after endoscopic resection of dysplasia or early adenocarcinoma. During the treatment phase, two doses will be tested consecutively starting with the lowest dose (1.2mm/sec). For each dose a total of 62 patients will be included. An interim analysis will be performed after treatment of the first 62 patients with lowest dose, before proceeding to treatment of additional 62 patients with a higher dose of 1.1mm/sec.
| Arm | Type | Receives |
|---|---|---|
| C2 CryoBalloon 180 Ablation System | Other | Device: C2 CryoBalloon 180° Ablation SystemC2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
- Prague Classification Score C≤3 and ≥M1
- Patients should be ablation-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
- Operable per institution's standards
Key exclusion criteria (13 listed)
- Esophageal stenosis preventing advancement of a therapeutic endoscope
- Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol.
- Prior ER of more than 2cm in length and/or >50% of the esophageal lumen circumference
- History of locally advanced (>SM1) esophageal cancer
- History of esophageal varices
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 |
|---|---|---|
| C2 CryoBalloon 180° Ablation SystemAlso: CryoBalloon 180The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes. | Device | C2 CryoBalloon 180 Ablation System |
Primary outcome
Efficacy: Dose response
Time frame: 10 weeks
Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Safety: Incidence of Dose-related SAEs
Time frame: 30 days
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
5 secondary outcomes
Incidence of AEs
Time frame: 30 days
Patient reported post-procedure pain
Time frame: 24hours, 7 days and 30 days post-procedure
Efficacy: Percent Regression
Time frame: 10 weeks
Efficacy: Treatment
Time frame: 10 weeks
Post procedure dysphagia score
Time frame: 24 hours, 7 days and 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Data will not be shared.
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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.
Bas LA Weusten, MD, PhD principal investigator
St. Antonius Ziekenhuis, Niewegein The Netherlands
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2 CryoBalloon 180° Ablation System in people with Barrett Esophagus, run by Merit Medical Systems, Inc. at 6 sites in Netherlands.
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 9 inclusion and 13 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 22 May 2026. 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 Netherlands. 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?
Efficacy: Dose response (time frame: 10 weeks). 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?
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 22 May 2026.