Coldplay 3 Clinical Trial

C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon® Focal Ablation System. Previous studies have shown that treatment using the CryoBalloon is safe.

The Coldplay CryoBalloon System has been cleared by the U.S. Food and Drug Administration (FDA), and the Coldplay 3 trial has been approved by the Institutional Review Board (IRB) at each hospital conducting the procedures.

US ONLY: The Coldplay CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with high grade dysplasia.

EU ONLY: The CryoBalloon Focal Ablation System is used to ablate unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s Esophagus and squamous dysplasia, by application of extreme cold.

 

What is expected of trial participant?

Participants will undergo treatment with the Coldplay CryoBalloon® Focal Ablation System and report their level of discomfort and difficulty swallowing during the first seven days after the procedure. Medication prescribed by the doctor must be taken.

Follow-up appointments for the first year after treatment will be conducted every 10 weeks until an endoscopic exam and biopsy reveal no Barrett’s esophagus. At each follow-up appointment, the doctor will conduct an endoscopic exam to look at the esophagus. The next step will depend on the finding:

• If there is no visible disease, the doctor will perform a biopsy.

• If there is visible disease, the patient will undergo another Cryoballoon treatment. Participants will again report any discomfort or swallowing difficulty.

 

What are the benefits to participation?

Participants will receive treatment that their doctors believe may be effective in treating their unwanted tissue. Additionally, each participant’s information will be used to understand the safety and effectiveness of the Coldplay CryoBalloon® Focal Ablation System; ultimately advancing available treatment options.

US ONLY: The Coldplay CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with high grade dysplasia.

EU ONLY: The CryoBalloon Focal Ablation System is used to ablate unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s Esophagus and squamous dysplasia, by application of extreme cold.


What information will be collected from participants?

1. Patient medical history – medical conditions, medications

2. CryoBalloon ablation treatment(s) – number of areas requiring treatment, how many ablations are done

3. Post-procedure experience – pain, difficulty swallowing

4. Progress – endoscopy and/or biopsy results from follow-up visits

5. Adverse events – medical problems or complications

 

Are there any associated risks with the procedures?

Possible complications are similar to those that can occur with current treatment techniques. There are no known additional adverse effects with balloon cryoablation. Short-term risks are those associated with local anesthesia and passing an endoscope through the esophagus. Complications that may occur with use of the CryoBalloon include perforation or laceration of the esophageal wall – these are both rare complications.

 

Will participants have any expenses?

All costs related to the procedure, device and diagnostic tests are billed to each patient’s medical insurance. Participants are responsible for travel costs to their appointments; however, if travel costs are a financial hardship, please speak to the research staff.

 

Please ask your doctor for more information.

US ONLY: The Coldplay CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with high grade dysplasia.

 

EU ONLY: The CryoBalloon Focal Ablation System is used to ablate unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s Esophagus and squamous dysplasia, by application of extreme cold.

C2 Therapeutics

303 Convention Way
Suite 1
Redwood City, CA 94063
(866) 515-3861