Barrett's EsophagusNCT01633411
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
An observational study of Barrett's Esophagus, run by Pentax Medical at 8 sites in 2 countries.
Trial summary
This is a feasibility study without a primary study hypothesis or statistical comparison. 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?
- Focal Cryoballoon Ablation System - 6 seconds, Focal Cryoballoon Ablation System - 8 seconds and CryoBalloon Focal Ablation System - 10 seconds
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2011to Jun 2014
- Phase
- Observational
- 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
Study population: Patients with Barrett's esophagus with or without dysplasia
Who may be able to join
- Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
- Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- Patient is deemed operable per standard institutional criteria.
Who cannot join
- Patient with endoscopically active inflammation in the treatment zone
- Esophageal stenosis preventing advancement of a therapeutic endoscope and/or 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
John Hopkins
Baltimore, Maryland, 21205
University of Southern California
Los Angeles, California, 90033
Columbia Medical Center
New York, New York, 10032
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
University of Rochester
Rochester, New York, 14642
Netherlands3 sites
Academic Medical Center Amsterdam
Amsterdam
St. Antonius Hospital
Nieuwegein
Universitair Medisch Centrum Utrecht
Utrecht
About this study
This is a feasibility study without a primary study hypothesis or statistical comparison.
Read the detailed description
The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.
Post-operative pain will be noted. Additionally, 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:
- Deployment ease/scope compatibility.
- Device malfunctions.
- Time of catheter deployment.
- Adverse events.
- Stricture formation at 6 to 8 weeks.
- Patient Pain.
- Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.
- Conditions
- Barrett's Esophagus
- Being tested
- Focal Cryoballoon Ablation System - 6 seconds, Focal Cryoballoon Ablation System - 8 seconds, CryoBalloon Focal Ablation System - 10 seconds
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Cryoballoon Ablation System - 6 secondsDevice
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
Focal Cryoballoon Ablation System - 8 secondsDevice
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
CryoBalloon Focal Ablation System - 10 secondsDevice
Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications".
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. Receives: Device: Focal Cryoballoon Ablation System - 6 seconds | |
| Cohort B | Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. Receives: Device: Focal Cryoballoon Ablation System - 8 seconds | |
| Cohort C | Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. Receives: Device: CryoBalloon Focal Ablation System - 10 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Stricture
Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope).
Measured: 6 to 8 Weeks
Secondary outcomes (2)
Post-procedure pain relative
A secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale (0 to 10). Patients is asked to score pain level in the treatment area and swallowing.
Measured: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
Presence of Residual Barrett's Esophagus
Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include:
- detailed description of the presence of Barrett's Esophagus and/or squamous mucosa.
- estimate of percentage of residual Barrett's in each sample
- the detailed description of any residual injury at all levels within the sample.
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2014
- Study completionJun 2014
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'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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bas L Weusten, MD, pHD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633411
- Sponsor's protocol ID
- CP-0003.A
- Status last verified
- Apr 2015
- First submitted
- 28 Jun 2012
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 21531411
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
- Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
- ClinicalTrials.gov ID
- NCT01633411
- Acronym / sponsor ID
- CP-0003.A
- Conditions
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jul 2012 (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.
This is a feasibility study without a primary study hypothesis or statistical comparison.
Detailed description
The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.
Post-operative pain will be noted. Additionally, 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:
- Deployment ease/scope compatibility.
- Device malfunctions.
- Time of catheter deployment.
- Adverse events.
- Stricture formation at 6 to 8 weeks.
- Patient Pain.
- Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: Focal Cryoballoon Ablation System - 6 secondsSubjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
| Cohort B | – | Device: Focal Cryoballoon Ablation System - 8 secondsSubjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
| Cohort C | – | Device: CryoBalloon Focal Ablation System - 10 secondsSubjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Barrett's esophagus with or without dysplasia
Key inclusion criteria (4 listed)
- Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
- Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- Patient is deemed operable per standard institutional criteria.
Key exclusion criteria (5 listed)
- Patient with endoscopically active inflammation in the treatment zone
- Esophageal stenosis preventing advancement of a therapeutic endoscope and/or 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.
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 |
|---|---|---|
| Focal Cryoballoon Ablation System - 6 secondsAblation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." | Device | Cohort A |
| Focal Cryoballoon Ablation System - 8 secondsAblation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." | Device | Cohort B |
| CryoBalloon Focal Ablation System - 10 secondsAblation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications". | Device | Cohort C |
Primary outcome
Esophageal Stricture
Time frame: 6 to 8 Weeks
Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope).
2 secondary outcomes
Post-procedure pain relative
Time frame: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
Presence of Residual Barrett's Esophagus
Time frame: 6 to 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 28 Apr 2022.
- Background: 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.
- Related InfoLink provided by the sponsor.
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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.
Bas L Weusten, MD, pHD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by Pentax Medical at 8 sites in 2 countries.
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 4 inclusion and 5 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 8 sites in United States, 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?
Esophageal Stricture (time frame: 6 to 8 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 NCT01633411, 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 28 Apr 2022.