Barrett's EsophagusNCT02249975
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
A study testing C2 CryoBalloon Focal Ablation System in people with Barrett's Esophagus, run by Pentax Medical at 2 sites in Netherlands.
Trial summary
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- C2 CryoBalloon Focal Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2015to 4 Oct 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
- Patient has a 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.
- Patient refuses or is unable to provide written informed consent.
- Patients that are pregnant.
- Patient with endoscopically active inflammation in the treatment zone.
- Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Center Amsterdam
Amsterdam
St. Antonius Hospital
Nieuwegein
About this study
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
Read the detailed description
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.
At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.
This study is:
- Prospective
- Multi-center
- Non-randomized
- Conditions
- Barrett's Esophagus
- Being tested
- C2 CryoBalloon Focal 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 Focal Ablation SystemDevice
The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.
Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.
Evaluations include, but are not limited to the following:
- Device malfunctions
- Adverse events
- Patient Pain
- Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.
| Study group | Role | What they receive |
|---|---|---|
| C2 CryoBalloon Focal Ablation System | Experimental | Cryoballoon ablation will be performed on patients with Barrett's Esophagus. Receives: Device: C2 CryoBalloon Focal Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of residual Barrett's Esophagus
Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
Measured: 12 weeks
Secondary outcomes (3)
Incidence of adverse events
All adverse events will be reported
Measured: 12 weeks
Patient Pain
Patient is asked to rate any pain in the treatment area or with swallowing
Measured: post-procedure through 12 week follow-up
Device Performance
All device performance will be reported
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJan 2015
- Primary completion29 Dec 2016
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Barrett's 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Bergman, MD, PhD, Principal investigator, Academic Medical Centre (Amsterdam)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249975
- Sponsor's protocol ID
- CP-0004.A
- Status last verified
- Feb 2018
- First submitted
- 24 Sep 2014
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.
PubMed 21531411van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.
PubMed 29928869
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
- ClinicalTrials.gov ID
- NCT02249975
- Acronym / sponsor ID
- CP-0004.A
- Conditions
- Barrett's Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 26 Sep 2014 (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.
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
Detailed description
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.
At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.
This study is:
- Prospective
- Multi-center
- Non-randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C2 CryoBalloon Focal Ablation System | Experimental | Device: C2 CryoBalloon Focal Ablation SystemCryoballoon ablation will be performed on patients with Barrett's Esophagus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
- Patient has a 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.
- Patient refuses or is unable to provide written informed consent.
- Patients that are pregnant.
- Patient with endoscopically active inflammation in the treatment zone.
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 Focal Ablation SystemThe C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken. Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following: * Device malfunctions * Adverse events * Patient Pain * Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus. | Device | C2 CryoBalloon Focal Ablation System |
Primary outcome
Presence of residual Barrett's Esophagus
Time frame: 12 weeks
Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
3 secondary outcomes
Incidence of adverse events
Time frame: 12 weeks
Patient Pain
Time frame: post-procedure through 12 week follow-up
Device Performance
Time frame: 12 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 28 Apr 2022.
- Results publication: PubMed 21531411Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.
- Derived from this study: PubMed 29928869van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.
- 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.
Jacques Bergman, MD, PhD principal investigator
Academic Medical Centre (Amsterdam)
2 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 Focal Ablation System in people with Barrett's Esophagus, run by Pentax Medical at 2 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 0 inclusion and 6 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 28 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 2 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?
Presence of residual Barrett's Esophagus (time frame: 12 weeks). 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 NCT02249975, which also lists 2 linked publications.
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 28 Apr 2022.