Phase 4 N=7 Randomized Treatment

Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

Barrett's Esophagus · Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00754468 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Depth of Injury — 4.0; 5.2 millimeters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cryo Spray Ablation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CSA Medical, Inc.
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Depth of Injury	4.0; 5.2	—
SECONDARY Side Effects of Subjects Receiving Cryospray Therapy.	2; 1	—

Summary

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Eligibility Criteria

Inclusion Criteria

Age 18 years of age
Esophagectomy planned based on clinical situation not related to this study.
Deemed operable based on institutional criteria.

Exclusion Criteria

Pregnant
Esophageal stricture preventing passage of endoscope or catheter.
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.
Refusal or inability to give consent.
Concurrent chemotherapy.
Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
Prior radiation therapy which involved the esophagus.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00754468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.