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Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT03097666
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.

Brief Summary:
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM Not Applicable

Detailed Description:

The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe 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 6 patients will be treated with Dose 1 (lowest).

All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues.

If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II.

If Dose 1 eradicates <80% of the treated BE, enrollment in Phase I will continue at the next highest dose. Treatment doses will be escalated in this manner until the earlier of a dose-related Serious Adverse Event (SAE) or determination of the therapeutic dose based on endoscopic exam.

When the therapeutic dose is determined, the study will proceed to Phase II to generate additional safety and efficacy data.

Phase II

Phase II will confirm the safety and efficacy of the therapeutic dose found in Phase I.

Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on 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 diagnostic 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.

When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018

Arm Intervention/treatment
C2 Cryoballoon Swipe Ablation System
C2 Cryoballoon Swipe Ablation System
Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM
The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.



Primary Outcome Measures :
  1. Safety [ 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.

  2. Efficacy: Percent Eradication by therapeutic dose [ Time Frame: 8 weeks ]
    Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.


Secondary Outcome Measures :
  1. Incidence of AEs [ Time Frame: up to 30 days post-treatment ]
    Incidence of all serious and non-serious adverse events up to 30 days post-treatment.

  2. Pain [ Time Frame: 24 hours and 7 days post-procedure ]
    Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)

  3. Efficacy: Percent Regression [ Time Frame: 8 weeks ]
    Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.

  4. Efficacy: Treatment [ Time Frame: 8 weeks ]
    Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.



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

Inclusion Criteria:

  1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:

    • Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
    • Residual BE with any grade of dysplasia after endoscopic resection
  2. Prague Classification Score C≤3
  3. Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
  4. Older than 18 years of age at time of consent
  5. Operable per institution's standards
  6. Provides written informed consent on the IRB-approved informed consent form
  7. Willing and able to comply with follow-up requirements

Exclusion Criteria:

  1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
  2. Any endoscopically visualized lesion such as ulcers, masses or nodules.
  3. History of locally advanced (>T1a) esophageal cancer
  4. History of esophageal varices
  5. Prior distal esophagectomy
  6. Active esophagitis LA grade B or higher
  7. Severe medical comorbidities precluding endoscopy
  8. Uncontrolled coagulopathy
  9. Pregnant or planning to become pregnant during period of study
  10. Patient refuses or is unable to provide written informed consent
  11. Participation in another study with investigational drug within the 30 days preceding or during the present study
  12. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

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): NCT03097666


Locations
Netherlands
AMC Medical Research B.V.
Amsterdam, Netherlands
St. Antonius Hospital Nieuwegein
Amsterdam, Netherlands
Catharina Ziekenhuis te Eindhoven
Eindhoven, Netherlands
Sponsors and Collaborators
C2 Therapeutics, Inc.

Responsible Party: C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03097666     History of Changes
Other Study ID Numbers: CP-0018
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases