Barrett EsophagusNCT03097666
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
A study testing C2 CRYOBALLOON SWIPE ABLATION SYSTEM in people with Barrett Esophagus, run by Pentax Medical at 3 sites in Netherlands.
Trial summary
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- C2 CRYOBALLOON SWIPE ABLATION SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesNetherlands
- Study dates
- 20 Mar 2017to 1 Nov 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
- Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
- Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
- Residual BE with any grade of dysplasia after endoscopic resection
- Prague Classification Score C≤3
- Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
Show all 9Show fewer
- Operable per institution's standards
- Provides written informed consent on the IRB-approved informed consent form
- Willing and able to comply with follow-up requirements
Who cannot join
- Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
- Any endoscopically visualized lesion such as ulcers, masses or nodules.
- History of locally advanced (>T1a) esophageal cancer
- History of esophageal varices
- Prior distal esophagectomy
- Active esophagitis LA grade B or higher
Show all 12Show fewer
- Severe medical comorbidities precluding endoscopy
- Uncontrolled coagulopathy
- Pregnant or planning to become pregnant during period of study
- Patient refuses or is unable to provide written informed consent
- Participation in another study with investigational drug within the 30 days preceding or during the present study
- General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
AMC Medical Research B.V.
Amsterdam
St. Antonius Hospital Nieuwegein
Amsterdam
Catharina Ziekenhuis te Eindhoven
Eindhoven
About this study
Official title: Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
Read the detailed description
The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 6 patients will be treated with Dose 1 (lowest).
All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues.
If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II.
If Dose 1 eradicates <80% of the treated BE, enrollment in Phase I will continue at the next highest dose. Treatment doses will be escalated in this manner until the earlier of a dose-related Serious Adverse Event (SAE) or determination of the therapeutic dose based on endoscopic exam.
When the therapeutic dose is determined, the study will proceed to Phase II to generate additional safety and efficacy data.
Phase II
Phase II will confirm the safety and efficacy of the therapeutic dose found in Phase I.
---------------------------------------------------------------
Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on 24 hours and seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.
- Conditions
- Barrett Esophagus
- Being tested
- C2 CRYOBALLOON SWIPE ABLATION SYSTEM
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2 CRYOBALLOON SWIPE ABLATION SYSTEMDevice
The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.
| Study group | Role | What they receive |
|---|---|---|
| C2 Cryoballoon Swipe Ablation System | Other | C2 Cryoballoon Swipe Ablation System Receives: Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-related SAEs
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Measured: 30 days
Efficacy: Percent Eradication by therapeutic dose
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Measured: 8 weeks
Secondary outcomes (4)
Incidence of AEs
Incidence of all serious and non-serious adverse events up to 30 days post-treatment.
Measured: up to 30 days post-treatment
Post-procedure pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)
Measured: 24 hours and 7 days post-procedure
Efficacy: Percent Regression
Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.
Measured: 8 weeks
Efficacy: Treatment
Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start20 Mar 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 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 Barrett EsophagusStudies 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
- Model description
- Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097666
- Sponsor's protocol ID
- CP-0018
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2017
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared.
Publications
Sunakawa H, Yoda Y, Nonaka S, Suzuki H, Abe S, Ishiguro Y, Ikeno T, Wakabayashi M, Sato A, Nakajo K, Kadota T, Yano T. Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on post-endoscopic resection scars: a CRYO-SCAR study (EPOC1902). Gastrointest Endosc. 2024 Sep;100(3):429-437. doi: 10.1016/j.gie.2024.02.018. Epub 2024 Feb 29.
PubMed 38431103
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03097666
- Acronym / sponsor ID
- CP-0018
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 31 Mar 2017 (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.
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
Detailed description
The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 6 patients will be treated with Dose 1 (lowest).
All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues.
If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II.
If Dose 1 eradicates <80% of the treated BE, enrollment in Phase I will continue at the next highest dose. Treatment doses will be escalated in this manner until the earlier of a dose-related Serious Adverse Event (SAE) or determination of the therapeutic dose based on endoscopic exam.
When the therapeutic dose is determined, the study will proceed to Phase II to generate additional safety and efficacy data.
Phase II
Phase II will confirm the safety and efficacy of the therapeutic dose found in Phase I.
---------------------------------------------------------------
Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on 24 hours and seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma
| Arm | Type | Receives |
|---|---|---|
| C2 Cryoballoon Swipe Ablation System | Other | Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEMC2 Cryoballoon Swipe Ablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
- Prague Classification Score C≤3
- Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
- Older than 18 years of age at time of consent
- Operable per institution's standards
Key exclusion criteria (12 listed)
- Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
- Any endoscopically visualized lesion such as ulcers, masses or nodules.
- History of locally advanced (>T1a) esophageal cancer
- History of esophageal varices
- Prior distal esophagectomy
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 CRYOBALLOON SWIPE ABLATION SYSTEMThe C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes. | Device | C2 Cryoballoon Swipe Ablation System |
Primary outcome
Dose-related SAEs
Time frame: 30 days
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Efficacy: Percent Eradication by therapeutic dose
Time frame: 8 weeks
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
4 secondary outcomes
Incidence of AEs
Time frame: up to 30 days post-treatment
Post-procedure pain
Time frame: 24 hours and 7 days post-procedure
Efficacy: Percent Regression
Time frame: 8 weeks
Efficacy: Treatment
Time frame: 8 weeks
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 22 Apr 2022.
- Derived from this study: PubMed 38431103Sunakawa H, Yoda Y, Nonaka S, Suzuki H, Abe S, Ishiguro Y, Ikeno T, Wakabayashi M, Sato A, Nakajo K, Kadota T, Yano T. Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on post-endoscopic resection scars: a CRYO-SCAR study (EPOC1902). Gastrointest Endosc. 2024 Sep;100(3):429-437. doi: 10.1016/j.gie.2024.02.018. Epub 2024 Feb 29.
- Individual participant dataSharing planned: No. Data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2 CRYOBALLOON SWIPE ABLATION SYSTEM in people with Barrett Esophagus, run by Pentax Medical at 3 sites in Netherlands.
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 12 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 22 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 3 sites in Netherlands. 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?
Dose-related SAEs (time frame: 30 days). The study lists 2 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 NCT03097666, 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 22 Apr 2022.