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

NCT02605759 | Completed

• 1 other identifier: CP-0013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.

Conditions

Esophageal Squamous Cell Dysplasia

Outcome Measures

Primary Outcomes (3)

• Serious, device-related adverse events

  Incidence of serious, device-related adverse events

  Day 30

• Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA)

  The percentage of subjects with successful, complete ablation of the USLs within the TA as determined by the endoscopist at the time of the treatment endoscopy(s)

  Day 0

• Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA

  Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA at three (3) months following endoscopic cryoablation. This will be evaluated by visual endoscopic exam and two (2) biopsies negative for squamous epithelial dysplasia confirmed by histopathological analysis

  3 months

Secondary Outcomes (5)

• Absence of USLs containing MGIN, HGIN or cancer

  12 months

• Complete eradication after one treatment

  12 months

• Device performance

  Day 0

• Procedure time

  Day 0

• Adverse Events

  12 Months

Study Arms (1)

CryoBalloon Focal Ablation System

EXPERIMENTAL

CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia

Device: CryoBalloon Focal Ablation System

Interventions

CryoBalloon Focal Ablation System DEVICE

Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia

Also known as: C2 CryoBalloon Focal Ablation System, Coldplay CryoBalloon Focal Ablation System

CryoBalloon Focal Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one unstained lesion (USL) in the esophagus upon high resolution endoscopy with Lugol's staining
• Flat (type 0-IIb) appearance of the USL
• Total area of USLs is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus
• Proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
• Older than 18 years of age at time of consent
• Operable per institution's standards
• Provides written informed consent on the Ethics Committee-approved informed consent form
• Willing and able to comply with study requirements for follow-up

You may not qualify if:

• Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone
• Other USLs containing MGIN, HGIN, or ESSC outside the designated treatment area
• Any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus
• Any previous esophageal surgery (except anti-reflux surgery)
• Any cancer (squamous cell or non-squamous cell) within the previous five (5) years
• Active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination
• Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
• Pregnant or planning to become pregnant during the study follow-up period
• Life expectancy ≤2 years

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (1)

• Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25.

  PMID: 30922862 DERIVED

Study Officials

• Guiqi Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 16, 2015
• Study Start: March 1, 2016
• Primary Completion: January 27, 2018
• Study Completion: January 27, 2018
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)