NCT02729727

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2016

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

April 28, 2022

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

March 14, 2016

Last Update Submit

April 21, 2022

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety of CryoBalloon Ablation System

    Incidence of device related serious adverse events

    through study completion, an average of 2 weeks

Secondary Outcomes (1)

  • Device Performance

    through study completion, an average of 2 weeks

Study Arms (1)

Single Arm

OTHER

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

Interventions

CryoBalloon Ablation SystemDEVICE

Tissue Ablation using CryoBalloon Ablation System

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patient refuses or is unable to provide written informed consent
  • Patient has esophageal narrowing limiting access to the intended site of ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre Amsterdam

Amsterdam, North Holland, 1105, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Jacques J.G.H.M. Bergman, MD, PhD

    AMC Medical Research B.V.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

April 6, 2016

Study Start

March 1, 2016

Primary Completion

June 24, 2016

Study Completion

June 30, 2016

Last Updated

April 28, 2022

Record last verified: 2018-01

Locations

NL(1)