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Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

NCT05405101 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-07-17

No results posted yet for this study

Summary

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria.

Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought.

* Frequency and severity of adverse events
* Length of inpatient stay
* Patient satisfaction
* Quality of life
* Return to activities of daily living

An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

Conditions

  • Primary Aldosteronism

Interventions

PROCEDURE

Thermal ablation of aldosterone producing adenoma.

On the left side, Radiofrequency ablation of aldosterone producing adenoma(s) will be undertaken via the stomach (endoscopically), under transgastric ultrasound guidance. On the right side, either Radiofrequency or Microwave Ablation of aldosterone producing adenoma(s) will be performed via a percutaneous approach, under CT guidance.

PROCEDURE

Unilateral adrenalectomy

Unilateral total adrenalectomy for aldosterone producing adenoma. This will be laparoscopic in the vast majority of patients, with open conversion if surgically indicated (unlikely in \>1-2 patients)

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Morris Brown · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405101 on ClinicalTrials.gov