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Cryotherapy -BEATS-RF Ablation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882478
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

Brief Summary:
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 or disease
Barrett's Esophagus With Persistent Dysplasia or Early Esophageal Adenocarcinoma Post Radio Frequency Ablation

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
Study Start Date : June 2013
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Group/Cohort
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



Primary Outcome Measures :
  1. Response [ Time Frame: 2 years ]
    To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA


Secondary Outcome Measures :
  1. Predictors of response [ Time Frame: 2 years ]
    To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882478


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kenneth K Wang, MD Mayo Clinic
Additional Information:
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Responsible Party: Kenneth K. Wang, Kathy and Russ VanCleve Professor of Gastroenterology Reserach, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01882478    
Other Study ID Numbers: 12-006030
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Keywords provided by Kenneth K. Wang, Mayo Clinic:
Barrett's esophagus
Early esophageal adenocarcinoma
Radio Frequency Ablation
Cryotherapy
Additional relevant MeSH terms:
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Adenocarcinoma
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases