NCT02729753

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 12, 2018

Completed
Last Updated

April 22, 2022

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

March 9, 2016

Results QC Date

March 27, 2018

Last Update Submit

April 21, 2022

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    2 weeks

Secondary Outcomes (2)

  • Device Performance: Average Procedure Time

    Minutes from start to end of procedure

  • Device Performance: Ease of Deployment of Device

    Minutes, from start to end of procedure

Study Arms (2)

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.

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.

Device: CryoBalloon™ Swipe Ablation System

Interventions

CryoBalloon™ Full Ablation SystemDEVICE

Tissue Ablation using CryoBalloon™ Full Ablation System

Also known as: CryoBalloon Ablation System (360)
CryoBalloon™ Full Ablation System
CryoBalloon™ Swipe Ablation SystemDEVICE

Tissue Ablation using CryoBalloon™ Swipe Ablation System

Also known as: CryoBalloon Ablation System (90)
CryoBalloon™ Swipe Ablation System

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Medical Center and Cancer Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

Title
Marcia Wachna, Director of Clinical Research
Organization
C2 Therapeutics
marcia@c2therapeutics.com

Study Officials

  • Brian Louie, MD

    Swedish Medical Center and Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 9, 2016

First Posted

April 6, 2016

Study Start

April 1, 2016

Primary Completion

October 24, 2016

Study Completion

October 30, 2016

Last Updated

April 22, 2022

Results First Posted

October 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)