Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Barrett Esophagus

Hyperplasia

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Central Nervous System Depressants

Antineoplastic Agents

Vitamins

Acetic Acid

Propofol

Retinol acetate

Endoscopic surveillance and PPI treatment

HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W

Endoscopic radiofrequency ablation

Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Endoscopic surveillance

Frederic PRAT, MD, PhD

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.

Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.

Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.

120 patients are planned to be included for at least 40 patients randomized in each group.

Primary endpoint: Prevalence of LGD in each group 3 years after randomization

Secondary endpoints:

* Prevalence of LGD in each group 1 and 5 years after randomization
* Rate of complete eradication of BE at 1, 3 and 5 years after randomization
* Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
* Rate of complications in RFA group after randomization
* Cost - efficacy comparison of the 2 strategies

Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Assistance Publique - Hôpitaux de Paris

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

cryo spray ablation applied to healthy tissue 2 cycles x20 seconds

Cryo Spray Ablation 4 cycles x 10 seconds treatment

Cryo Spray Ablation

Cryo Spray Ablation 2 cycles x 20 seconds

Afonso Ribeiro, M.D.

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.

The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date.

All subjects will receive narcotic analgesics to control symptoms.

Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.

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

A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)

histopathological findings analyzed to determine max depth of injury (mm)

University of Miami

CSA Medical, Inc.

Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.

CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold.

Group 1

Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.

CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold.

Group 2

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Dr. Alfonso Ribeiro

cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment

Group 1: Cryo Spray Ablation

cryo spray ablation applied to healthy tissue 2 cycles x20 seconds

Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds

Group 2: Cryo Spray Ablation

Depth of Injury

Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment

Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds

Side Effects of Subjects Receiving Cryospray Therapy.

Overall Study

Stomach Neoplasms

Metaplasia

Stomach Diseases

Stomach Cancer

Dominique LAMARQUE, MD, PhD

This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

As secondary objectives, among the patients included in the cohort, the study will:

* assess the incidence of low grade dysplasia,
* assess the incidence of high grade dysplasia in patients with low grade dysplasia,
* identify risk factors of progression to dysplasia and gastric cancer.

This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.

All patients will undergo an endoscopy with gastric sampling in order to biopsy:

* 1 sample each in anterior and posterior surfaces of antrum
* 1 sample in lesser curvature
* 1 sample each in anterior and posterior surfaces of body of stomach

Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.

During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:

* patients with intestinal metaplasia: gastroscopy at 36 months.
* patients with dysplasia: an annual gastroscopy will be performed.

In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:

* 4 circumferential samplings of antrum
* 1 sampling of curvature
* 4 circumferential samplings of body of stomach

Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Incidence of gastric cancer or high grade dysplasia of the gastric mucosa during the 3-year follow-up.

Percentage of development of low grade dysplasia in patients initially with intestinal metaplasia without dysplasia.

Percentage of development in 3 years of gastric cancer or high grade dysplasia lesion, in patients initially with low grade dysplasia.

Société nationale française de gastro-entérologie

Ann Murphy Legg, RN

The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia	NCT01360541	Barrett Oesopha... Low Grade Dyspl...	Endoscopic radi... Endoscopic surv...	18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.	NCT00754468	Barrett's Esoph... Esophageal Canc...	Cryo Spray Abla... Cryo Spray Abla...	18 Years -	CSA Medical, Inc.
Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia	NCT02325323	Stomach Cancer		18 Years -	Assistance Publique - Hôpitaux de Paris
CryoSpray Ablation (TM) GI Patient Registry	NCT00747448	Barrett's Esoph... Esophageal Canc...		18 Years -	CSA Medical, Inc.

Spots Global Cancer Trial Database for low grade dysplasia