NCT00650988

Brief Summary

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2005

Typical duration for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

March 30, 2008

Last Update Submit

December 21, 2012

Conditions

Barretts EsophagusEsophageal Cancer

Keywords

Barrett's EsophagusCryospray ablationHigh Grade DysplasiaEarly Esophageal CancersEsophageal NeoplasmsEsophageal Intramucosal Cancer (IMCA)Esophageal Cancer limited to esophageal wallBarretts esophagus High Grade Dysplasia (HGD)

Outcome Measures

Primary Outcomes (2)

  • Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.

    Determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia)

    at 12 months from start of treatment

  • Number of patients that experience toxicity with cryotherapy

    Toxicity is defined as death or esophageal perforation

    at 12 months from start of therapy

Secondary Outcomes (1)

  • Assess the degree of tumor ablation of inoperable early esophageal cancer

    at 12 months from start of therapy

Study Arms (2)

Barrett's Esophagus with intramucosal carcinoma (IMCA)

EXPERIMENTAL
Procedure: Cryospray Ablation

Barrett's Esophagus with High Grade Dysplasia (HGD)

EXPERIMENTAL
Procedure: Cryospray Ablation

Interventions

Cryospray AblationPROCEDURE

Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.

Barrett's Esophagus with High Grade Dysplasia (HGD)Barrett's Esophagus with intramucosal carcinoma (IMCA)

Eligibility Criteria

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

You may qualify if:

  • Group 1:
  • Co-morbid conditions such as severe heart, lung, kidney or liver disease.
  • Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.
  • Group 2:
  • Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall

You may not qualify if:

  • Age less than 18 years
  • Co-morbid illness expected to cause death within 6 months
  • Pregnancy
  • Refusal or inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Barrett EsophagusEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Study Officials

  • John A. Dumot, D.O.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

September 1, 2005

Primary Completion

May 1, 2008

Study Completion

December 1, 2008

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations

US(1)