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Completed

NCT Number: NCT01882478

Cryotherapy -BEATS-RF Ablation Trial

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).

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Key information

Conditions

Barrett's Esophagus With Persistent Dysplasia or Adenocarcinoma Of Esophagus Barrett Esophagus Digestive System Diseases Early Esophageal Adenocarcinoma Post Radio Frequency Ablation Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2013
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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