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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00526786
Other study ID # 16-00016-00
Secondary ID
Status Terminated
Phase Phase 4
First received September 5, 2007
Last updated March 12, 2014
Start date September 2007
Est. completion date September 2009

Study information

Verified date March 2014
Source CSA Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.


Recruitment information / eligibility

Status Terminated
Enrollment 78
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

- Prior adenocarcinoma involving the esophagus or stomach.

- Prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.

Study Design


Intervention

Device:
CryoSpray Ablation System (510(k) NO: K070893)
no drug interventions specified

Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Universtiy of North Carloina at Chapel Hill Chapel Hill North Carolina
United States Cleveland Clinic Foundation Cleveland Ohio
United States Baylor University Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Hoboken Universtiy Medical Center Hoboken New Jersey
United States Lancaster Reginal Medical Center Lancaster Pennsylvania
United States Columbia University Medical Center New York New York
United States Norwalk Hospital Norwalk Connecticut
United States University of California -Irvine Orange California
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
CSA Medical, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Ell C, May A, Gossner L, Pech O, Günter E, Mayer G, Henrich R, Vieth M, Müller 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. — View Citation

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. — View Citation

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. — View Citation

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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