NCT00526786

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

16 active sites

Status
terminated

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

September 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

September 5, 2007

Last Update Submit

March 12, 2014

Conditions

Barrett's EsophagusHigh Grade DysplasiaLow Grade Dysplasia

Keywords

Low Grade DysplasiaHigh Grade DysplasiaBarrett's EsophagusCryospray ablationICECryotherapyCryoCryoSpray

Outcome Measures

Primary Outcomes (1)

  • The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.

    2 years post treatment

Secondary Outcomes (1)

  • 1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.

    2 years post treatment

Interventions

CryoSpray Ablation System (510(k) NO: K070893)DEVICE

no drug interventions specified

Also known as: 510(k) NO: K070893

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Karnofsky performance status of 50-100%
  • Life expectancy greater than 5 years
  • Hematopoietic, Hepatic and Renal lab clearance
  • Previous endoscopy with histological confirmation of LGD or HGD within BE
  • For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery.
  • For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS).

You may not qualify if:

  • Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years).
  • Esophageal stricture preventing passage of endoscope or catheter.
  • Active esophagitis
  • EMR performed less than 8 weeks prior to CSA treatment.
  • EMR performed on greater than 90% circumference of any area of the esophagus.
  • Any previous esophageal surgery, except fundoplication without complications.
  • Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
  • Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints.
  • Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol.
  • Medically unfit or other contraindication to tolerate upper endoscopy.
  • Inability to tolerate therapy with a proton pump inhibitor (PPI).
  • Refusal or inability to give consent.
  • Other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free).
  • Concurrent chemotherapy.
  • Prior radiation therapy which involved the esophagus.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of California -Irvine

Orange, California, 92868, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hoboken Universtiy Medical Center

Hoboken, New Jersey, 07030, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Universtiy of North Carloina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Lancaster Reginal Medical Center

Lancaster, Pennsylvania, 17604, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Baylor University

Dallas, Texas, 75246, United States

Location

Related Publications (6)

  • Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.

    PMID: 8076761BACKGROUND

  • Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

    PMID: 8995932BACKGROUND

  • Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.

    PMID: 10734018BACKGROUND

  • Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.

    PMID: 10385730BACKGROUND

  • Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.

    PMID: 14629105BACKGROUND

  • Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.

    PMID: 16301023BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Bruce Greenwald, M.D.

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 10, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

US(16)