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

Primary Purpose

Esophageal Squamous Cell Dysplasia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CryoBalloon Focal Ablation System
Sponsored by
Pentax Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CryoBalloon Focal Ablation System

Arm Description

CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia

Outcomes

Primary Outcome Measures

Serious, device-related adverse events
Incidence of serious, device-related adverse events
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)
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

Secondary Outcome Measures

Absence of USLs containing MGIN, HGIN or cancer
Efficacy defined as the absence of USLs containing MGIN, HGIN or cancer within the original TA after the last endoscopic ablation.
Complete eradication after one treatment
Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System
Device performance
Device performance, assessed by Device malfunction
Procedure time
Procedure time, defined as the time from the introduction of the endoscope to its removal
Adverse Events
Incidence of all treatment-related and serious, non-device related adverse events

Full Information

First Posted
November 13, 2015
Last Updated
April 18, 2022
Sponsor
Pentax Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02605759
Brief Title
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Official Title
Clinical Study to Evaluate the Safety, Feasibility and Efficacy of the Coldplay CryoBalloon Focal Ablation System for the Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 27, 2018 (Actual)
Study Completion Date
January 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pentax Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
Detailed Description
Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CryoBalloon Focal Ablation System
Arm Type
Experimental
Arm Description
CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia
Intervention Type
Device
Intervention Name(s)
CryoBalloon Focal Ablation System
Other Intervention Name(s)
C2 CryoBalloon Focal Ablation System, Coldplay CryoBalloon Focal Ablation System
Intervention Description
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
Primary Outcome Measure Information:
Title
Serious, device-related adverse events
Description
Incidence of serious, device-related adverse events
Time Frame
Day 30
Title
Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA)
Description
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)
Time Frame
Day 0
Title
Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Absence of USLs containing MGIN, HGIN or cancer
Description
Efficacy defined as the absence of USLs containing MGIN, HGIN or cancer within the original TA after the last endoscopic ablation.
Time Frame
12 months
Title
Complete eradication after one treatment
Description
Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System
Time Frame
12 months
Title
Device performance
Description
Device performance, assessed by Device malfunction
Time Frame
Day 0
Title
Procedure time
Description
Procedure time, defined as the time from the introduction of the endoscope to its removal
Time Frame
Day 0
Title
Adverse Events
Description
Incidence of all treatment-related and serious, non-device related adverse events
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqi Wang, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30922862
Citation
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.
Results Reference
derived

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

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