Esophageal Squamous Cell DysplasiaNCT02605759
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
A study testing CryoBalloon Focal Ablation System in people with Esophageal Squamous Cell Dysplasia, run by Pentax Medical at 1 site in China.
Trial summary
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Dysplasia
- What is being tested?
- CryoBalloon Focal Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to 27 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
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
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
Read the 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.
- Conditions
- Esophageal Squamous Cell Dysplasia
- Being tested
- CryoBalloon Focal Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoBalloon Focal Ablation SystemDevice
Also called C2 CryoBalloon Focal Ablation System, Coldplay CryoBalloon Focal Ablation System
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
| Study group | Role | What they receive |
|---|---|---|
| CryoBalloon Focal Ablation System | Experimental | CryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia Receives: Device: CryoBalloon Focal Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious, device-related adverse events
Incidence of serious, device-related adverse events
Measured: 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)
Measured: 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
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 12 months
Complete eradication after one treatment
Percentage of subjects achieving complete eradication after one treatment session with the CryoBalloon Ablation System
Measured: 12 months
Device performance
Device performance, assessed by Device malfunction
Measured: Day 0
Procedure time
Procedure time, defined as the time from the introduction of the endoscope to its removal
Measured: Day 0
Adverse Events
Incidence of all treatment-related and serious, non-device related adverse events
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startMar 2016
- Primary completion27 Jan 2018
- Study completion27 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guiqi Wang, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605759
- Sponsor's protocol ID
- CP-0013
- Status last verified
- Apr 2022
- First submitted
- 13 Nov 2015
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30922862
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02605759
- Acronym / sponsor ID
- CP-0013
- Conditions
- Esophageal Squamous Cell Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 27 Jan 2018 (actual)
- Study completion
- 27 Jan 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CryoBalloon Focal Ablation System | Experimental | Device: CryoBalloon Focal Ablation SystemCryoBalloon Focal Ablation for the treatment of esophageal squamous cell dysplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoBalloon Focal Ablation SystemAlso: C2 CryoBalloon Focal Ablation System, Coldplay CryoBalloon Focal Ablation SystemPositioned 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 | Device | CryoBalloon Focal Ablation System |
Primary outcome
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
5 secondary outcomes
Absence of USLs containing MGIN, HGIN or cancer
Time frame: 12 months
Complete eradication after one treatment
Time frame: 12 months
Device performance
Time frame: Day 0
Procedure time
Time frame: Day 0
Adverse Events
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 30922862Ke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiqi Wang, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CryoBalloon Focal Ablation System in people with Esophageal Squamous Cell Dysplasia, run by Pentax Medical at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious, device-related adverse events (time frame: Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.