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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:9/16/2018
Start Date:March 2016
End Date:May 2021
Contact:Marcia Wachna, RN
Email:marcia@c2therapeutics.com
Phone:650-996-2183

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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the
treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy
and safety of the System in treatment of patients with previously untreated (treatment naïve)
low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of
five (5) ablation treatment sessions during their 12 months of study participation to achieve
complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as
needed to treat the dysplastic areas are allowed in each treatment session at the discretion
of the investigator.

Inclusion Criteria:

- Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic
BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer
(ImCA) is identified during patient screening, this may be treated with Endoscopic
Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous
EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with
ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative
for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.

- BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1

- Older than 18 years of age at time of consent

- Operable per institution's standards

- Provides written informed consent on the approved informed consent form

- Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

- Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis

- Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope
(patients may have the stenosis/stricture dilated and then be treated with CryoBalloon
ablation under this protocol at a subsequent procedure ≥2 weeks later)

- Symptomatic untreated strictures

- Any endoscopically-visualized abnormalities such as ulcers, masses or nodules.
Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment
under this protocol.

- History of esophageal cancer more extensive than T1a or not meeting criteria for low
risk of recurrence (confirmed by EMR pathology results negative for positive margin,
poorly differentiated carcinoma, and lymphovascular invasion)

- History of esophageal varices

- Large (>4cm) hiatal hernia

- Prior distal esophagectomy

- Any clinical or histological suspicion of esophageal adenocarcinoma invading into the
submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive
deep margin by EMR

- Active esophagitis grade B or higher

- Severe medical comorbidities precluding endoscopy

- Uncontrolled coagulopathy

- Pregnant or planning to become pregnant during period of study participation

- Patient refuses or is unable to provide written informed consent

- Life expectancy ≤3 years, as judged by the site investigator

- General poor health, multiple co-morbidities placing the patient at risk or otherwise
unsuitable for trial participation
We found this trial at
11
sites
New York, New York 10032
Principal Investigator: Julian Abrams, MD
Phone: 212-304-5686
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333 South Columbia Street
Chapel Hill, North Carolina 27599
Principal Investigator: Nicholas J. Shaheen, MD, MPH
Phone: 919-843-5884
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Irving Waxman, MD
Phone: 773-926-8490
University of Chicago One of the world's premier academic and research institutions, the University of...
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Baltimore, Maryland 21287
Principal Investigator: Mimi Canto, MD
Phone: 410-502-2893
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Cleveland, Ohio 44012
Principal Investigator: Amitabh Chak, MD
Phone: 216-844-3853
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: David Diehl, MD
Phone: 570-214-5420
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Manhasset, New York 11030
Principal Investigator: Arvind Trindad, MD
Phone: 516-321-8017
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101 The City Drive South
Orange, California 92868
Principal Investigator: Kenneth Chang, MD
Phone: 714-456-2215
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Orange, CA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Anthony Infantolino, MD
Phone: 215-503-2545
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Rochester, Minnesota 55905
Principal Investigator: Prasad G. Iyer, MD
Phone: 507-293-5307
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: F. Scott Corbett, MD
Phone: 941-365-6556
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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