Clinical Trial Summary

The C2 CryoBalloon® Ablation System…

Is Effective: The rate of Complete Response, Dysplasia (CR-D) was 92% and for Complete Response, Intestinal Metaplasia (CRIM) it was 84% at 12 months after 2 treatments.

Offers a Favorable Safety Profile: Two of 40 patients (5%) experienced stricture and one patient (2.5%) with High Grade Dysplasia (HGD) “was hospitalized for bleeding after resuming aspirin.”

Is Tolerable: Twenty-three percent (8/35) of patients required use of narcotics post-ablation, but pain and narcotic use did not last beyond 48 hours. Patients’ average score was 2 on the 10-point Likert scale immediately following ablation.

SOURCE: Canto MI et al. Multifocal Nitrous Oxide CryoBalloon Ablation With or Without EMR for Treatment of Neoplastic Barrett’s Esophagus: Preliminary Results of a Prospective Clinical Trial In Treatment Naïve and Previously Ablated Patients. Poster presentation at the 24th UEG Week, Vienna, Austria, 2016.

To learn more about C2 Therapeutics’ clinical trials and the end points (claims) they address, please select an end point below to expand the section and review supporting evidence.

Authors Title with Hyperlink Where Presented or Published NCT Number* Patient Population Results
Canto MI, Shin EJ, Khashab MA, et al. Multifocal Nitrous Oxide Cryoballoon Ablation with or without EMR for Treatment of Neoplastic Barrett’s Esophagus Poster presentation at the 24th UEG Week, Vienna, Austria, 2016.

NCT02534233

BE (HGD, LGD)
37 Enrolled

  • 92% CRD, 84% CRIM
  • 3% SAE
  • 0% Narcotics at 48 Hours
Authors Title with Hyperlink Where Presented or Published NCT Number* Patient Population Results
Canto, et al Multifocal Nitrous Oxide Cryoballoon Ablation with or without EMR for Treatment of Neoplastic Barrett’s Esophagus Poster presentation at the 24th UEG Week, Vienna, Austria, 2016.

NCT02534233

BE (HGD, LGD)
37 Enrolled

  • 92% CRD, 84% CRIM
  • 3% SAE
  • 0% Narcotics at 48 Hours
Künzli, et al Efficacy of the CbFAS for the Eradication of Dysplastic Barrett’s Esophagus Islands Endoscopy. 2017; 49(02): 169-175

 NCT02249975

BE (HGD, LGD) 30 Enrolled

  • 100% CRD, 100% CRIM
  • 0% SAE
  • 90% Pain Free at 48 Hours
Sitaraman, et al Use of the CbFAS for the Eradication of Esophageal Neoplasia: A Single-Center Experience Gastroenterology. 2016 April; Volume 150, Issue 4, Supplement 1, Page S266.

BE
19 Enrolled

  • CbFAS Feasible, Safe for Patients with Treatment-Resistant Neoplasia
Wang, et al Multi-Center Experience with the CbFAS for Esophageal Dysplasia Gastrointestinal Endoscopy 2015 May; Volume 81, Issue 5, Supplement, Page AB522

NCT02230410

BE, ESCN, IMC
7 Enrolled

  • 86% CRD
  • 0% SAE

 

Authors Title with Hyperlink Where Presented or Published NCT Number* Patient Population Results
John, et al Cryoballoon Ablation for Barrett’s Esophagus: A Prospective Single Operator Learning Curve and Time-Efficiency Study Gastrointestinal Endoscopy. 2017 May; Volume 85, Issue 5, Supplement, Page AB560

74 Enrolled

  • Learning Curve for CryoBalloon Ablation is 18 Procedures, After Which Efficiency Plateaus
Authors Title with Hyperlink Where Presented or Published NCT Number* Patient Population Results
Van Munster, et al Post-Procedural Pain After Endoscopic Ablation Therapy of Barrett’s Esophagus: Is Cryo Ablation Less Painful Compared with Radiofrequency Ablation? Gastrointestinal Endoscopy. 2017 May; Volume 85, Issue 5, Supplement, Page AB568

BE
17 Enrolled

Pain Reported at 48 Hours

  • 18% Severe Pain for Cryo
  • 46% Severe Pain for RFA
Künzli, et al Efficacy of the CbFAS for the Eradication of Dysplastic Barrett’s Esophagus Islands Endoscopy. 2017; 49(02): 169-175

NCT02249975

BE
30 Enrolled

  • 100% CRD, 100% CRIM
  • 0% SAE
  • 90% Pain Free at 48 Hours
Canto, et al Multifocal Nitrous Oxide Cryoballoon Ablation with or without EMR for Treatment of Neoplastic Barrett’s Esophagus Poster presentation at the 24th UEG Week, Vienna, Austria, 2016

NCT02534233

BE (HGD, LGD)
37 Enrolled

  • 92% CRD, 84% CRIM
  • 3% SAE
  • 0% Narcotics at 48 Hours
Schölvinck, et al Treatment of Barrett’s Esophagus with a Novel Focal Cryoablation Device: a Safety and Feasibility Study Endoscopy. 2015 Dec; 47(12):1106-12.

NCT01633411

39 Enrolled

  • 100% Complete Response at 10 Seconds
  • 0% SAE
  • 86% Pain-Free at 48 Hours
Wang, et al Multi-Center Experience with the CbFAS for Esophageal Dysplasia Gastrointestinal Endoscopy. 2015 May; Volume 81, Issue 5, Supplement, Page AB522

NCT02230410

BE, ESCN, IMC
7 Enrolled
  • 86% CRD
  • 0% SAE

Authors Title with Hyperlink Where Presented or Published NCT Number* Patient Population Results
Louie, et al Evaluation of a Novel Swipe CryoBalloon Ablation System in Bench, Porcine, and Human Esophagus Models Gastrointestinal Endoscopy. 2017 May; Volume 85, Issue 5, Supplement, Page AB513

6 Enrolled

  • Uniform 3cm-Long Mucosal Ablation Confirmed
  • 0% Adverse Events
Schölvinck, et al Treatment of Barrett’s Esophagus with a Novel Focal Cryoablation Device: a Safety and Feasibility Study Endoscopy. 2015 Dec; 47(12):1106-12.

NCT01633411

39 Enrolled

  • 100% Complete Response at 10 Seconds
  • 0% SAE
  • 86% Pain-Free at 48 Hours
Schölvinck, et al Deep Tissue Ablation with Little or No Late Fibrosis: Animal and Human Data on Esophageal Cryoablation Using the New CbFAS Gastrointestinal Endoscopy. 2014 May; Volume 79, Issue 5, Supplement, Page AB520

8 Enrolled

  • Mucosal Ablation Confirmed
DeMeester, et al Initial Human Experience with a Novel Through-the-Scope Cryoballoon Device for Mucosal Ablation Gastroenterology. 2012 May; Volume 142, Issue 5, Supplement 1, Page S-1038

NCT01293448

13 Enrolled

  • Mucosal Ablation Confirmed
  • Necrosis Reached the Submucosa or Muscularis Propria in All Patients
Friedland, et al A Novel Device for Ablation of Abnormal Esophageal Mucosa Gastrointestinal Endoscopy. 2011 Jul;74(1):182-8.

      —

 

  • Device Determined Simple-To-Use
  • Maximal Effect for Animal Esophagus Achieved at 12 Seconds
Authors Title with Hyperlink Where Presented or Published NCT Number* Enrolled Subjects Results
Ke, et al Focal Cryoballoon Ablation for Eradication of Esophageal Squamous Cell Neoplasia: A Prospective Trial, Interim-Results for 43 Patients Gastrointestinal Endoscopy. 2017 May; Volume 85, Issue 5, Supplement, Page AB507

NCT02605759

Squamous (HGIN, MGIN)
43 Enrolled

  • 88% CR
  • 0% SAE
Canto, et al Nitrous Oxide Cryotherapy for (ESCN) Gastrointestinal Endoscopy. 2016 May; Volume 83, Issue 5, Supplement, Page AB567

9 Enrolled

  • 100% CR
  • 0% SAE or Strictures
Patel, et al Endoscopic Management of Refractory GAVE With Cryoballoon Therapy: A Case Series Gastrointestinal Endoscopy. 2017 May; Volume 85, Issue 5, Supplement, Page AB501

 10 Enrolled

  • 0% Adverse Events
  • 0% Requiring Transfusion 4-Weeks Post-Treatment

*CLINICALTRIALS.GOV IDENTIFIER (NCT NUMBER) – A unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is “NCT” followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.

Acronyms:

BE Barrett’s Esophagus
CbFAS CryoBalloon Focal Ablation System
CR Complete Response
CRD Complete Response, Dysplasia
CRIM Complete Response, Intestinal Metaplasia
EMR Endoscopic Mucosal Resection
ESCN Esophageal Squamous Cell Neoplasia
GAVE Gastric Antral Vascular Ectasia
HGD High Grade Dysplasia
IMC Intramucosal Cancer
LGD Low Grade Dysplasia
SAE Severe Adverse Event
MKTG 1067 REV A