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NCT Number: NCT07126535

Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Patients undergoing ablative therapy for management of dysplastic Barrett's Esophagus (BE) will have decreased distensibility over the course of treatment, but improvement in mucosal impedance as BE epithelia is replaced by neosquamous epithelia. This information may lead to further research in predicting therapeutic response and complications. The purpose of this research is to collect information while measuring changes related to the esophagus in patients that receive radiofrequency ablation (RFA) for dysplastic Barrett's Esophagus (BE) or esophageal cancer. Study participation includes measurements of the esophagus with the use of two different devices. This takes place during clinically indicated upper endoscopies during the timeframe the participant is receiving RFA treatments. This process will take up to an additional 10 minutes during the upper endoscopy and be done while the participant is sedated.

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Key information

Conditions

Dysplastic Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions Radiofrequency Ablation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Don Codipilly, MD

PRINCIPAL_INVESTIGATOR

Mariah J. Robran

CONTACT

[email protected]

507-266-3595

Michele L. Johnson

CONTACT

507-255-5504

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female ≥ 18 years of age
  • Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)
  • Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)
  • Willing to undergo multiple rounds of endoscopic eradication therapy (EET) for management of BE (which is the guideline clinical recommendation for management of this disease)

Exclusion criteria

  • History of esophageal ablation
  • History of esophageal stricture
  • History of esophageal or gastric surgery
  • Pregnancy
  • History of esophageal cancer treated with radiation or chemotherapy
  • History of achalasia
  • History of delayed gastric emptying confirmed by 4-hour gastric emptying study
  • Received injection of glucagon like peptide 1 agonists within a few days prior to EGD
  • Adults lacking the capacity to consent for self

Treatment and study plan

Radiofrequency ablation alone

Diagnostic Test

If there is no evidence of nodularity, these patients will undergo RFA. Clinical biopsies utilizing a large-capacity biopsy forceps (Radial Jaw 4, Boston Scientific, Marlborough, MA) are obtained. RFA may be delivered through several devices under the BarrX RFA System (Medtronic USA, Minnetonka, MN), including a circumferential balloon catheter (Halo 360; figure 1), or over the scope focal catheter (Halo 90 or 60). The Halo 360 treats a circumferential 4 cm segment at a time, whereas the focal catheters treat a 1.3x2 cm (Halo 90) or 1.0x1.5 cm (Halo 60) area.

Primary outcomes

  1. Changes in distensibility index (DI)

    Time frame: Every 12 weeks, up to 1 year (4 visits)

    Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.

  2. Changes in diameter

    Time frame: Every 12 weeks, up to 1 year (4 visits)

    Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.

Secondary outcomes

  1. Changes in mucosal impedance

    Time frame: Every 12 weeks, up to 1 year (4 visits)

    Damage to the mucosal lining of the esophagus and measurement of esophageal leakiness will be assessed by sensors used during RFA procedure.

Other outcomes

  1. GERD-Q Questionnaire

    Time frame: Every 12 weeks, up to 1 year (4 visits)

    The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) IS a 6-item questionnaire used to help diagnose GERD and assess the impact of symptoms on a patient's daily life. Scores range from 0-18 with higher scores indicating greater GERD symptoms.

  2. Reflux symptom index (RSI)

    Time frame: Every 12 weeks, up to 1 year (4 visits)

    The RSI is used to measure impact of GERD symptoms over the past month. It consists of 9 symptoms which are rated on a scale of 0-5 where 0=no problem and 5=significant problem. Higher scores indicate greater impact of symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariah J Robran

CONTACT

[email protected]

(507)266-3595

Michele L Johnson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Mar 30, 2026

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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