Esophageal CancerNCT02729753

Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

A study testing CryoBalloon™ Full Ablation System and CryoBalloon™ Swipe Ablation System in people with Esophageal Cancer, run by Pentax Medical at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophageal Cancer
What is being tested?: CryoBalloon™ Full Ablation System and CryoBalloon™ Swipe Ablation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Apr 2016to 30 Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
Older than 18 years of age
Requires a clinically necessary esophagectomy for esophageal cancer or other indications.

Who cannot join

Patient has esophageal narrowing limiting access to the intended sites of ablation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

MD Anderson Cancer Center
Houston, Texas, 77030
Swedish Medical Center and Cancer Institute
Seattle, Washington, 98122

Other trials in United States

About this study

Official title: Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Read the detailed description

The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Conditions: Esophageal Cancer
Being tested: CryoBalloon™ Full Ablation System, CryoBalloon™ Swipe Ablation System
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CryoBalloon™ Full Ablation SystemDevice
Also called CryoBalloon Ablation System (360)
Tissue Ablation using CryoBalloon™ Full Ablation System
CryoBalloon™ Swipe Ablation SystemDevice
Also called CryoBalloon Ablation System (90)
Tissue Ablation using CryoBalloon™ Swipe Ablation System

Study groups in NCT02729753
Study group	Role	What they receive
CryoBalloon™ Full Ablation System	Other	To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. Receives: Device: CryoBalloon™ Full Ablation System
CryoBalloon™ Swipe Ablation System	Other	To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy. Receives: Device: CryoBalloon™ Swipe Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of the CryoBalloon™ Full and Swipe Ablation System
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Measured: 2 weeks
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment.
Dose response by effect of ablation to submucosa:
0: Normal
1. Inflammatory cell infiltration
2. Separation with inflammation
3. Edema and Necrosis
Measured: 2 weeks

Secondary outcomes (2)

Device Performance: Average Procedure Time
Average Procedure time as measured from start to finish of ablation.
Measured: Minutes from start to end of procedure
Device Performance: Ease of Deployment of Device
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
Measured: Minutes, from start to end of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201630 Oct 2016

First posted6 Apr 2016 (estimated)
Study startApr 2016
Primary completion24 Oct 2016
Study completion30 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal CancerStudies 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: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02729753
Sponsor's protocol ID: CP0014
Status last verified: Sep 2018
First submitted: 9 Mar 2016
Last updated: 22 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
ClinicalTrials.gov ID: NCT02729753
Acronym / sponsor ID: CP0014
Conditions: Esophageal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pentax MedicalIndustry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: 24 Oct 2016 (actual)
Study completion: 30 Oct 2016 (actual)
First posted: 6 Apr 2016 (estimated)
Results: Posted 12 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CryoBalloon™ Full Ablation System	Other	Device: CryoBalloon™ Full Ablation SystemTo evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
CryoBalloon™ Swipe Ablation System	Other	Device: CryoBalloon™ Swipe Ablation SystemTo evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
Older than 18 years of age
Requires a clinically necessary esophagectomy for esophageal cancer or other indications.

Key exclusion criteria (1 listed)

Patient has esophageal narrowing limiting access to the intended sites of ablation

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™ Full Ablation SystemAlso: CryoBalloon Ablation System (360)Tissue Ablation using CryoBalloon™ Full Ablation System	Device	CryoBalloon™ Full Ablation System
CryoBalloon™ Swipe Ablation SystemAlso: CryoBalloon Ablation System (90)Tissue Ablation using CryoBalloon™ Swipe Ablation System	Device	CryoBalloon™ Swipe Ablation System

Primary outcome

Safety of the CryoBalloon™ Full and Swipe Ablation System
Time frame: 2 weeks
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
Time frame: 2 weeks
Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment. Dose response by effect of ablation to submucosa: 0: Normal 1. Inflammatory cell infiltration 2. Separation with inflammation 3. Edema and Necrosis

2 secondary outcomes

Device Performance: Average Procedure Time
Time frame: Minutes from start to end of procedure
Device Performance: Ease of Deployment of Device
Time frame: Minutes, from start to end of procedure

Results and safety

Results posted to the registry on 12 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CryoBalloon™ Full Ablation System	3	3
CryoBalloon Swipe Ablation System	7	6

Primary outcome: Safety of the CryoBalloon™ Full and Swipe Ablation System

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	CryoBalloon™ Swipe Ablation System n = 6	CryoBalloon™ Full Ablation System n = 3
Value	0	0

Primary outcome: Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems

Time frame: 2 weeks. Number. Unit: units on a scale

Measure	CryoBalloon™ Full Ablation System n = 3	CryoBalloon™ Swipe Ablation System n = 6
0.5mm/sec : Immediate esophagectomy	2	0
0.5mm/sec : Esophagectomy 5 days Post	3	1
0.6mm/sec : Immediate esophagectomy	1	2
0.8mm/sec :Immediate esophagectomy	–	2
0.8mm/sec : Esophagectomy 5 days Post	–	1
0.9mm/sec : Immediate esophagectomy	–	1

Population analysed: Submucosal evaluation done for patients at differing doses.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CryoBalloon™ Full Ablation System	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
CryoBalloon™ Swipe Ablation System	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): 1. Due to recruitment difficulties, dosimetry data is limited. 2. Pre-clinical studies largely performed on porcine squamous esophageal epithelium as BE pre-clinical models are unavailable. Porcine esophageal wall layers are generally thinner.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Esophageal Cancer

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
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Mitral Regurgitation

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.

Brian Louie, MD principal investigator

Swedish Medical Center and Cancer Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CryoBalloon™ Full Ablation System and CryoBalloon™ Swipe Ablation System in people with Esophageal Cancer, run by Pentax Medical at 2 sites in United States.

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 3 inclusion and 1 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 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety of the CryoBalloon™ Full and Swipe Ablation System (time frame: 2 weeks). 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 NCT02729753.

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.