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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus

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.

Detailed Summary:

The procedure will be performed on an outpatient basis according to the site standard of care for anesthesia and sedation during esophagogastroduodenoscopy (EGD) procedures.

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:

Phase I The first two patients (subject 1-2) will be treated with Dose 1 (lowest). As many applications as needed to ablate 50% of the esophageal circumference will be done. If there is no Dose-related SAE within seven (7) days post-treatment, another four (4) patients (subject 3-6) will be treated in the same fashion, for a total of 6 patients treated with Dose 1.

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 (median percentage in all 6 patients based on the EGD-Adjudication Committee evaluation), 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 (median percentage in treated patients as assessed by EGD-Adjudication Committee), enrollment in Phase I will continue with a 0.1mm/sec increase in dose (0.7mm/sec; Second 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 and biopsy.

Sponsor: C2 Therapeutics, Inc.

Current Primary Outcome:

  • Safety: Safety will be evaluated by the 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 greater than 6 (on VAS) on 24 hours AND 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation 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 DSMB for relationship to the dose and severity.
  • Efficacy:Dose response (efficacy) is defined as eradication percentage of BE [ Time Frame: 8 weeks ]
    Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after two-step circumferential treatment with the therapeutic dose. The eradication percentage will be assessed by the EGD-AC, consisting of at least two (2) physicians specialized in gastroenterology, by comparing pre-treatment and follow-up digital images of the ablated areas in a systematic and standardized manner.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence: Incidence of all serious and non-serious adverse events up to 30 days post-treatment [ Time Frame: up to 30 days post-treatment ]
    Incidence of all serious and non-serious adverse events up to 30 days post-treatment
  • 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)
  • Efficacy, regression percentage [ Time Frame: 8 weeks ]
    Regression percentage at the first follow-up endoscopy, after 1 treatment covering 50% of circumference of the esophagus with the therapeutic dose.
  • Efficacy of treatment [ Time Frame: 8 weeks ]
    4. Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 semi-circumferential and after fully circumferential treatment


Original Secondary Outcome: Same as current

Information By: C2 Therapeutics, Inc.

Dates:
Date Received: March 1, 2017
Date Started: March 20, 2017
Date Completion: June 30, 2018
Last Updated: March 30, 2017
Last Verified: March 2017