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Active, not recruitingNo phase

C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.

Key facts

Who runs it
Merit Medical Systems, Inc.
Where
Netherlands6 sites in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
62 people enrolled
Started
16 Jan 2023
Expected to end
18 Dec 2026
Type of study
Interventional
Treatments tested
  • C2 CryoBalloon 180° Ablation System
Record updated
22 May 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • 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
  • Prior distal esophagectomy
  • Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study
  • History of locally advanced (>SM1) esophageal cancer
  • History of esophageal varices
  • Esophageal stenosis preventing advancement of a therapeutic endoscope
  • 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
  • General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • C2 CryoBalloon 180 Ablation SystemOther group

    C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
22 May 2026