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NCT01868139 · ClinicalTrials.gov registry record · NA

Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)

A NA study, sponsored by University of Maryland, Baltimore.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT01868139: Clinical Trial NA study, sponsored by University of Maryland, Baltimore.

NCT01868139 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01868139, a NA study, was terminated before completion, sponsored by University of Maryland, Baltimore.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including surgery, chemotherapy, radiation therapy, and endoscopic resection. It is hypothesized that one of the two following outcomes will occur: 1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site; 2. Stable disease: tumor remission is not attained, but disease progression is halted.

Primary Outcome

The primary endpoint is to determine the response rate to spray cryotherapy. It is hypothesized that one of the two following outcomes will occur: 1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site; 2. Stable disease: tumor remission is not attained, but disease progression is halted.

Interventions

  • DEVICE Liquid nitrogen spray cryotherapy with the truFreeze device

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2013-06
Est. Completion 2014-12
Phase NA
University of Maryland, Baltimore

560 total trials

Why NCT01868139 stopped before completion

NCT01868139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Liquid nitrogen spray cryotherapy with the truFreeze device is the first listed.

NCT01868139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01868139 about?

NCT01868139 is a clinical study titled "Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)". The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including surgery, chemotherapy, radiat...

What is the current status of trial NCT01868139?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2013-06. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01868139?

The interventions under investigation include: Liquid nitrogen spray cryotherapy with the truFreeze device (DEVICE).

Who is sponsoring clinical trial NCT01868139?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01868139's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01868139, the US trial registry maintained by the National Library of Medicine. NCT01868139 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.