Clinical Trial Summary

//Clinical Trial Summary
Clinical Trial Summary 2018-05-30T19:48:05+00:00

C2 Therapeutics was founded a decade ago to offer a new standard for simplicity in the ablation of esophageal disease aiming at the prevention and management of esophageal cancer. Our technology – the C2 CryoBalloon® Ablation System – was designed with 3 principles in mind:

Predictable Efficacy

Repeatedly deliver therapy in a controlled, defined ablation zone at consistent temperatures to induce effective and long-lasting destruction of diseased tissue.

Acceptable Tolerability and Minimal Complications

Create a therapeutic tool that is well-tolerated by patients post-procedure that also has a low rate of complications.

Usability and Portability

Design a system that requires no expensive capital investment and offers portability among endoscopy suites.

The single largest area of investment for the company is clinical research, with the goal of validating these principles through data collection and analysis. To accomplish this, C2 Therapeutics has:

  • 9 completed clinical trials
  • 3 trials currently enrolling or in follow-up stages
  • 5 trials in planning stages

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Current Clinical Trials

Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System (ColdPlayIII)

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of “treatment-naïve” (previously untreated) Barrett’s Esophagus (BE). Outcome measures include eradication of all dysplasia, eradication of all esophageal intestinal metaplasia, incidence of serious adverse events, and incidence of post-procedure pain.  Patients with low or high-grade untreated dysplastic BE are enrolled based on relevant inclusion and exclusion criteria.  The study is being conducted at 11 centers in the United States.

Read more about this clinical trial by clicking on the clinicaltrials.gov identifier here: NCT02514525

C2 CryoBalloon™ 180 Ablation System Dose Escalation Study

To determine the safety and efficacy of the C2 CryoBalloon™ Swipe 180 Ablation System (“CryoBalloon Swipe”) used at increasing doses. Outcome measures include safety (incidence of dose-related SAE) and dose response, as eradication percentage of BE.  Patients with low-grade dysplasia (LGD) or high-grade dysplasia (HGD) in BE are enrolled based on relevant inclusion and exclusion criteria.  The study is being conducted at 5 centers in the Netherlands.

Read more about this clinical trial by clicking on the clinicaltrials.gov identifier here: NCT03311451

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

To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia. Outcome measures include complete ablation of the USLs (unstained lesions) within the treatment area, absence of USLs with MGIN (medium-grade intraepithelial neoplasia) or HGIN (high-grade intraepithelial neoplasia) or cancer, and incidence of serious adverse events.  Patients with MGIN or HGIN are enrolled based on releavant inclusion and exclusion criteria.  The study is being conducted in China.

Read more about this clinical trial by clicking on the clinicaltrials.gov identifier here: NCT02605759

 

 

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