Coldplay Cryoablation of Dysplastic Squ… | Clinical Trial

Key information

Conditions

Esophageal Squamous Cell Dysplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: C2 CryoBalloon Focal Ablation System, Coldplay CryoBalloon Focal Ablation System

Primary outcomes

Serious, device-related adverse events

Time frame: Day 30

Incidence of serious, device-related adverse events
Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA)

Time frame: Day 0

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

Time frame: 3 months

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 outcomes

Absence of USLs containing MGIN, HGIN or cancer

Time frame: 12 months

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

Time frame: 12 months

Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System
Device performance

Time frame: Day 0

Device performance, assessed by Device malfunction
Procedure time

Time frame: Day 0

Procedure time, defined as the time from the introduction of the endoscope to its removal
Adverse Events

Time frame: 12 Months

Incidence of all treatment-related and serious, non-device related adverse events

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Nov 16, 2015
Registry last updated: Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.