Trial record 7 of 144 for:    barretts and mayo

Cryotherapy -BEATS-RF Ablation Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01882478
First received: June 18, 2013
Last updated: February 11, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).


Condition
Barrett's Esophagus With Persistent Dysplasia or
Early Esophageal Adenocarcinoma After Radio Frequency Ablation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA


Secondary Outcome Measures:
  • Predictors of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy


Estimated Enrollment: 15
Study Start Date: June 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
failure to respond to RF ablation
patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions in a cohort of patients undergoing endoscopic therapy.

Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Able to provide informed consent
  • Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
  • Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
  • Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment

Exclusion Criteria:

  • Age younger than 18 years old
  • Life expectancy less than 12 months
  • Pregnancy
  • Presence of esophageal varices
  • Esophageal stricture precluding passage of an endoscope and suction tubing
  • Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
  • Esophageal cancer (T2 and above)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882478

Contacts
Contact: Lori S Lutzke 507-255-7495 lutzke.lori@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori S Lutzke    507-255-7495    lutzke.lori@mayo.edu   
Principal Investigator: Kenneth K Wang, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kenneth K. Wang, Kathy and Russ VanCleve Professor of Gastroenterology Reserach, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01882478     History of Changes
Other Study ID Numbers: 12-006030
Study First Received: June 18, 2013
Last Updated: February 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus
Early esophageal adenocarcinoma
Radio Frequency Ablation
Cryotherapy

Additional relevant MeSH terms:
Barrett Esophagus
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 01, 2015