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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 22, 2026 (before its estimated June 18, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Lead sponsor: Pentax Medical to Merit Medical Systems, Inc.v7 Show 8 more changesShow less
    • Primary completion date: Aug 1, 2025 to Jun 18, 2026
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 62
    • Study sites: 5 to 6
    • Study completion date: Dec 1, 2026 to Dec 18, 2026
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 5
    • Study description shortened, about 24 words
  2. Study completion date: Dec 1, 2025 to Dec 1, 2026v6
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv5 Show 5 more changesShow less
    • Start date changed from estimate of Jan 7, 2023 to Jan 16, 2023
    • Secondary endpoints revised (4)
    • Study description shortened, about 32 words
    • Study sites revised (5)
    • Study title revised
  4. Primary completion date: Aug 2018 to Aug 1, 2025v4 Show 4 more changesShow less
    • Start date: Jan 7, 2018 to Jan 7, 2023
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Oct 2018 to Dec 1, 2025
    • Site details revised at 5 of 5 sites
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2018 to Jan 7, 2018
    • Site details revised at 5 of 5 sites
    v3
  6. Start date: Nov 2017 to Jan 2018
    • Study sites: 1 to 5
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03311451
Lead Sponsor Merit Medical Systems, Inc.
Conditions
(from sponsor)		 Barrett Esophagus
Related terms Barrett Esophagus
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov