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Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

Sponsor
Pentax Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT02729727
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
4
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Condition or Disease Intervention/Treatment Phase
  • Device: CryoBalloon Ablation System
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jun 24, 2016
Actual Study Completion Date :
Jun 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Single Arm

To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Device: CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System

Outcome Measures

Primary Outcome Measures

  1. Safety of CryoBalloon Ablation System [through study completion, an average of 2 weeks]

    Incidence of device related serious adverse events

Secondary Outcome Measures

  1. Device Performance [through study completion, an average of 2 weeks]

    Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation

  • Older than 18 years of age at the time of consent

  • Requires a clinically-necessary esophagectomy for esophageal cancer

  • Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)

Exclusion Criteria:

  • Patient refuses or is unable to provide written informed consent

  • Patient has esophageal narrowing limiting access to the intended site of ablation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Academic Medical Centre Amsterdam Amsterdam North Holland Netherlands 1105

Sponsors and Collaborators

  • Pentax Medical

Investigators

  • Principal Investigator: Jacques J.G.H.M. Bergman, MD, PhD, AMC Medical Research B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pentax Medical
ClinicalTrials.gov Identifier:
NCT02729727
Other Study ID Numbers:
  • CP-0008
First Posted:
Apr 6, 2016
Last Update Posted:
Apr 28, 2022
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided

Study Results

No Results Posted as of Apr 28, 2022