Expired Study
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Clinical Trial 4631

Baltimore, MD 21201

Study Summary:

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

Qualified Participants Must:

• Be 18-85 years of age
• Have Karnofsky performance status of 50-100%
• Have life expectancy greater than 5 years
• Previous endoscopy with histological confirmation of LGD or HGD within BE with a minimum endoscopic length of 2 cm from the top of the gastric folds (TGF) to the proximal margin of the top of intestinal metaplasia, including islands (TIM). Biopsies during this endoscopy were performed every 2 cm or less in 4 quadrants along the entire segment of BE
• Have previous endoscopy with histological confirmation of LGD or HGD within BE with a maximum endoscopic length of 6 cm from the TGF to the TIM. Biopsies during this endoscopy were performed every 2 cm or less in 4 quadrants along the entire segment of BE
• Be 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
• Have an endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS)
• Not be pregnant, be practicing adequate contraception, not intend to become pregnant, or be lactating at any time during the study (approximately 2 years)
• Not have any esophageal stricture preventing passage of endoscope and decompression tube
• Not have active esophagitis
• Not have known or suspected eosinophilic esophagitis or other disease that inhibits the elasticity of the esophagus or stomach such as Amyloidosis and Marfan’s Syndrome
• Have no history of endoscopic mucosal resection (EMR) that meets any of the following criteria:

  • EMR performed less than 8 weeks prior to CSA treatment.
  • EMR performed on greater than 90% circumference of any area of the esophagus

• Not have any previous esophageal surgery except fundoplication without complications
• Not have a 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
• Not be enrolled in an investigational drug or device trial that clinically interferes with the ICE Dysplasia endpoints
• Not have psychiatric or other illness deemed by the investigator as an inability to comply with this protocol
• Not be considered medically unfit or have contraindications to tolerate upper endoscopy
• Not have an inability to tolerate therapy with a proton pump inhibitor (PPI)
• Not have any other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free)
• Not have concurrent chemotherapy
• Not have had prior radiation therapy which involved the esophagus
• Not have had prior adenocarcinoma involving the esophagus or stomach
• Not have had prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.

Qualified Participants May Receive:

Evaluation of inclusion/exclusion criteria, previous interventions, and group placement; Medical history; Blood Draw-sent to a certified micro lab for CBC, BUN/CR, LFT’s, and pregnancy test if female of child bearing age; Imaging (Group 2 only); Endoscopic ultrasound, with evaluation of the esophageal wall at 12 MHz or higher and evaluation of the mediastinum and upper abdomen for evidence of abnormal lymph nodes.

Subjects will be scheduled for EGD with cryotherapy on designated days according to the study timeline. Subjects will be interviewed prior to the procedure using a standardized questionnaire This questionnaire will specifically solicit symptoms of chest pain, abdominal pain, irregular heart rate, dysphagia or odynophagia, fever, nausea, vomiting or other symptoms;

Sedation as per standard EGD sedation guidelines at the institution will be administered and staff investigators will perform the EGD using a diagnostic upper endoscope with adherence to standard protocol. A modified oral-gastric tube, the “cryo decompression tube” or “CDT” (to allow decompression of both the stomach and the esophagus), will be inserted orally using a Seldinger technique with a Savory wire.

The Cryocatheter will be passed into the channel of the endoscope and extended approximately one cm beyond the distal tip of the scope. Liquid nitrogen will be sprayed through the Cryocatheter, which causes a white frost (cryofrost) on the adjacent mucosa. The spray will be applied for 10 seconds as measured by the integrated device timer. After each 10 second application of cryospray, the treatment area will be allowed to thaw no less than 45 seconds before initiating subsequent cryospray applications. The process of applying the CryoSpray and thawing for no less than 45 seconds will be repeated 4 times in piecemeal fashion such that any given treated area will be maintained in a cryofrost (white) state for a total of 40 seconds. The entire BE segment will be treated in one session.

Subjects will be contacted in one week by telephone to assess for any immediate complications. A questionnaire will be completed by the study personnel. Subjects will be seen the same day in the clinic or endoscopy center for any serious concerns as determined by the subject or study personnel.

Subjects will return in 6 to 8 weeks (+/- 2 weeks) for reassessment with a repeat EGD and cryotherapy for residual abnormal mucosa. The Side Effect Questionnaire will be repeated before each EGD.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.