Clinical trial NCT02605759: 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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Squamous Cell Dysplasia
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2015-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serious, device-related adverse events
timeFrame: Day 30
measure: Successful, complete ablation of the unstained lesions (USLs) within the treatment area (TA)
timeFrame: Day 0
measure: Percentage of subjects with absence of ULS containing medium-grade intraepithelial neoplasia (MGIN) or high-grade intraepithelial neoplasia (HGIN) within the original TA
timeFrame: 3 months
Secondary outcomes:
measure: Absence of USLs containing MGIN, HGIN or cancer
timeFrame: 12 months
measure: Complete eradication after one treatment
timeFrame: 12 months
measure: Device performance
timeFrame: Day 0
measure: Procedure time
timeFrame: Day 0
measure: Adverse Events
timeFrame: 12 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Guiqi Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.