Esophageal Squamous Epithelium DysplasiaNCT05349240
C2 Esophageal Squamous Epithelium Dysplasia
A study testing C2 CryoBalloonTM Ablation System. in people with Esophageal Squamous Epithelium Dysplasia, run by Pentax Medical at 4 sites in China.
Trial summary
This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Epithelium Dysplasia
- What is being tested?
- C2 CryoBalloonTM Ablation System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 4 sitesChina
- Study dates
- 18 Nov 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of 18 to 80 years old (including 18 and 80 years old).
- At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.
- Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.
- No potential of lymph node metastasis by preoperative comprehensive evaluation.
- Male or female of 18 to 80 years old (including 18 and 80 years old).
- At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.
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- Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.
- No potential of lymph node metastasis by preoperative comprehensive evaluation.
- The patients are self volunteered to participate in the trial and will sign an informed consent form prior to enroll.
Who cannot join
- Females who are pregnant, lactating or plan to get pregnant during the study.
- Known hypersensitivity to iodine.
- Lesions within the target area such as: obvious ulcer; varices at risk of bleeding; active inflammation due to esophageal reflux into the treatment area; lesions view being not flat, or containing unfavourable unstained lesions (USLs) outside the designated treatment areas.
- Esophageal stenosis preventing the passage of the endoscope to the treatment area. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4 cm of the treatment area.
- Having previously received Heller surgery: any previous ablative esophageal surgery (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any previous esophageal surgery except for anti-reflux surgery.
- Suffering from any cancer in the past 5 years.
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- Severe bleeding potential; patients on anti-coagulative therapy or stopping using anti-coagulative drugs for less than 7 days before enrollment or with impaired coagulation.
- 9) Patients with unstable vital signs 10) Anti-human immunodeficiency virus (HIV) antibody positive, both syphilis serology Treponema pallidum-specific antibody test and rapid plasma reagin positive.
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
GUIQI WANG, MD, 0086-10-87788547, wangguiq@126.com
YAN KE, 0086-13520186688, keyan@cicams.ac.cn
- Recruiting
The First Bethune Hospital of Jilin University
Changchun
HONG XU, MD, 0086-13756661648, chxuhong@163.com
HONG XU, MD
- Recruiting
Changzhi People's Hospital
Changzhi
SHAOFENG WANG, MMS, 0086-13509759693, czsxjcyxlt@163.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
ZHIJIE FENG, MD, 0086-15803210958, zhijiefeng2005@163.com
ZHIJIE FENG, MD
About this study
Official title: A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia
This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.
- Conditions
- Esophageal Squamous Epithelium Dysplasia
- Being tested
- C2 CryoBalloonTM Ablation System.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2 CryoBalloonTM Ablation System.Device
Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues.
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | All subjects will receive treatment with the study device. Receives: Device: C2 CryoBalloonTM Ablation System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
Percentage of complete remission at 12 months
Measured: 12 Month
Secondary outcomes (2)
1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment
Percentage of patients who need only 1 treatment
Measured: 12 Month
2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start18 Nov 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Epithelium 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
- 129 participants (estimated)
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
- NCT05349240
- Sponsor's protocol ID
- CBAS_DIII_19001
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2022
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of C2 CryoBalloonTM Ablation System in Patients With Esophageal Squamous Epithelium Dysplasia
- ClinicalTrials.gov ID
- NCT05349240
- Acronym / sponsor ID
- CBAS_DIII_19001
- Conditions
- Esophageal Squamous Epithelium Dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Apr 2022 (actual)
- 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.
This study will evaluate the efficacy and safety of C2 CryoBalloonTM Ablation System for the cryoablation of dysplastic squamous tissue in patients with moderate to severe esophageal squamous epithelium dysplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Device: C2 CryoBalloonTM Ablation System.All subjects will receive treatment with the study device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female of 18 to 80 years old (including 18 and 80 years old).
- At least one unstained lesion (USL) in the esophagus upon high resolution upper gastrointestinal endoscopy with Lugol's staining. Flat (Paris type 0-IIb) USL, with the total area of one or more USLs having a maximum longitudinal size of 6 cm and covering a maximum of one-half of the esophageal circumference.
- Patients with one or more biopsy confirmed esophageal squamous epithelium dysplasia areas within 6 months prior to enrollment, and the pathological diagnosis is moderate to severe esophageal squamous epithelium dysplasia.
- No potential of lymph node metastasis by preoperative comprehensive evaluation.
- Male or female of 18 to 80 years old (including 18 and 80 years old).
Key exclusion criteria (9 listed)
- Females who are pregnant, lactating or plan to get pregnant during the study.
- Known hypersensitivity to iodine.
- Lesions within the target area such as: obvious ulcer; varices at risk of bleeding; active inflammation due to esophageal reflux into the treatment area; lesions view being not flat, or containing unfavourable unstained lesions (USLs) outside the designated treatment areas.
- Esophageal stenosis preventing the passage of the endoscope to the treatment area. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4 cm of the treatment area.
- Having previously received Heller surgery: any previous ablative esophageal surgery (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any previous esophageal surgery except for anti-reflux surgery.
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 |
|---|---|---|
| C2 CryoBalloonTM Ablation System.Cryoablation is used to ablate the tissue under the cryogenic condition. The device is mainly used to destroy the unhealthy tissues. | Device | Study Intervention |
Primary outcome
Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area
Time frame: 12 Month
Percentage of complete remission at 12 months
2 secondary outcomes
1) Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial by one time of treatment
Time frame: 12 Month
2) Percentage of patients with complete remission of all the moderate to severe dysplasia in initial treatment area
Time frame: 12 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Esophageal Squamous Epithelium Dysplasia
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
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.
Guiqi Wang, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2 CryoBalloonTM Ablation System. in people with Esophageal Squamous Epithelium Dysplasia, run by Pentax Medical at 4 sites 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 9 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guiqi Wang, MD (0086-10-87788547, wangguiq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who have complete remission of all the moderate to severe dysplasia in initial treatment area (time frame: 12 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025.