Barrett's EsophagusNCT01293448
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
A study testing Cryoballoon Ablation in people with Barrett's Esophagus and Esophageal Cancer, run by Pentax Medical at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus, Esophageal Cancer
- What is being tested?
- Cryoballoon Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2010to Jan 2012
- 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
- Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
- Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent Form (IFC) using a form 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's esophagectomy is clinically necessary due to reasons unrelated to this study.
- Patient is deemed operable per standard institutional criteria.
Who cannot join
- Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent. - -
- Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
- Patient has esophageal narrowing limiting access to the intended site of ablation.
- Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
- Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Southern California
Los Angeles, California, 90033
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
University of Rochester
Rochester, New York, 14642
About this study
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
Read the detailed description
The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Being tested
- Cryoballoon Ablation
- Keywords
- Esophagectomy, Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon AblationDevice
Also called CryoBalloon Ablation System, cryoablation
Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study. Receives: Device: Cryoballoon Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect
The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
Measured: Within 30 days of ablation procedure
Secondary outcomes (2)
Post-ablation symptoms
A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
Measured: Within 7 days of ablation procedure
Post procedure pain
The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
Measured: Within 7 days of ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Bergman, MD, Principal investigator, AIDS Malignancy ConsortiumSteve DeMeester, MD, Principal investigator, University of Southern CaliforniaBlair Jobe, MD, Principal investigator, University of PittsburghJeffery Peters, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293448
- Sponsor's protocol ID
- CP-0001.A
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2010
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
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 Balloon-based Cryoablation of Human Esophageal Epithelium
- ClinicalTrials.gov ID
- NCT01293448
- Acronym / sponsor ID
- CP-0001.A
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Keywords
- Esophagectomy, Barrett's Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Feb 2011 (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 evaluate a cryoablation technique used to ablate human esophageal mucosa.
Detailed description
The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Cryoballoon AblationCryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
- Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent Form (IFC) using a form 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's esophagectomy is clinically necessary due to reasons unrelated to this study.
Key exclusion criteria (6 listed)
- Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent. - -
- Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
- Patient has esophageal narrowing limiting access to the intended site of ablation.
- Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
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 AblationAlso: CryoBalloon Ablation System, cryoablationDevice: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825) | Device | Intervention |
Primary outcome
Treatment effect
Time frame: Within 30 days of ablation procedure
The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
2 secondary outcomes
Post-ablation symptoms
Time frame: Within 7 days of ablation procedure
Post procedure pain
Time frame: Within 7 days of ablation procedure
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.
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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 principal investigator
AIDS Malignancy Consortium
Steve DeMeester, MD principal investigator
University of Southern California
Blair Jobe, MD principal investigator
University of Pittsburgh
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon Ablation in people with Barrett's Esophagus and Esophageal Cancer, run by Pentax Medical at 4 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 6 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 4 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?
Treatment effect (time frame: Within 30 days of ablation procedure). 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 28 Apr 2022.