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Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

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ClinicalTrials.gov Identifier: NCT02605759
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.

Brief Summary:
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Dysplasia Device: CryoBalloon Focal Ablation System Not Applicable

Detailed Description:
Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Study Start Date : March 2016
Actual Primary Completion Date : January 27, 2018
Actual Study Completion Date : January 27, 2018

Arm Intervention/treatment
Experimental: CryoBalloon Focal Ablation System
CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia
Device: CryoBalloon Focal Ablation System
Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia
Other Names:
  • C2 CryoBalloon Focal Ablation System
  • Coldplay CryoBalloon Focal Ablation System




Primary Outcome Measures :
  1. Serious, device-related adverse events [ Time Frame: Day 30 ]
    Incidence of serious, device-related adverse events

  2. Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA) [ Time Frame: Day 0 ]
    The percentage of subjects with successful, complete ablation of the USLs within the TA as determined by the endoscopist at the time of the treatment endoscopy(s)

  3. Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA [ Time Frame: 3 months ]
    Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA at three (3) months following endoscopic cryoablation. This will be evaluated by visual endoscopic exam and two (2) biopsies negative for squamous epithelial dysplasia confirmed by histopathological analysis


Secondary Outcome Measures :
  1. Absence of USLs containing MGIN, HGIN or cancer [ Time Frame: 12 months ]
    Efficacy defined as the absence of USLs containing MGIN, HGIN or cancer within the original TA after the last endoscopic ablation.

  2. Complete eradication after one treatment [ Time Frame: 12 months ]
    Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System

  3. Device performance [ Time Frame: Day 0 ]
    Device performance, assessed by Device malfunction

  4. Procedure time [ Time Frame: Day 0 ]
    Procedure time, defined as the time from the introduction of the endoscope to its removal

  5. Adverse Events [ Time Frame: 12 Months ]
    Incidence of all treatment-related and serious, non-device related adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least one unstained lesion (USL) in the esophagus upon high resolution endoscopy with Lugol's staining
  • Flat (type 0-IIb) appearance of the USL
  • Total area of USLs is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus
  • Proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
  • Older than 18 years of age at time of consent
  • Operable per institution's standards
  • Provides written informed consent on the Ethics Committee-approved informed consent form
  • Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

  • Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone
  • Other USLs containing MGIN, HGIN, or ESSC outside the designated treatment area
  • Any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus
  • Any previous esophageal surgery (except anti-reflux surgery)
  • Any cancer (squamous cell or non-squamous cell) within the previous five (5) years
  • Active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination
  • Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
  • Pregnant or planning to become pregnant during the study follow-up period
  • Life expectancy ≤2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605759


Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
C2 Therapeutics, Inc.
Investigators
Principal Investigator: Guiqi Wang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party: C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02605759     History of Changes
Other Study ID Numbers: CP-0013
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No