New Needle-Free treatment could replace surgery for adrenal tumors

NCT ID NCT05368090

Disease control Sponsor: Haukeland University Hospital Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new, less invasive procedure called EUS-RFA to standard surgery for treating left-sided adrenal tumors that cause high blood pressure and other hormone-related issues. About 60 participants will receive the new procedure, which uses a thin tube inserted through the mouth to deliver heat and destroy the tumor. Researchers will check if it controls hormone levels as well as surgery, with fewer side effects and a shorter hospital stay.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: radiofrequency ablation (RFA) delivered via endoscopic ultrasound
What this could lead to: If successful, this could offer a less invasive alternative to surgery for controlling hormone overproduction in primary aldosteronism, reducing recovery time and complications.
What could go wrong: This is an early-stage study with only 60 participants, so results may not apply broadly. The procedure carries risks like bleeding or infection, and it may not control hormone levels as effectively as surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria all groups * Signed written informed consent * If CT scan shows an adrenal nodule to the same adrenal as AVS lateralisation result: nodule size \< 4 cm and enhancement criteria for adrenal adenoma (native hounsfield units \< 10 or relative wash-out \> 40% or absolute wash-out \> 60%) PA unilateral group inclusion criteria: * Age 18 to 60 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria * AVS lateralisation to left adrenal (lateralisation index ≥ 4,0) PA "debulking" group inclusion criteria: * Age 18 to 70 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria MACS unilateral and debulking group inclusion criteria: * Age 18 to 80 years * MACS diagnosis confirmed according to ENSAT/ECE Guideline criteria * AVS lateralisation to the left adrenal, and visible left adrenal tumor on CT scan OR bilateral overproduction of cortisol on AVS, and bilateral tumors/hyperplasia on CT scan (debulking) Exclusion Criteria all groups: * CT scan suspicion of adrenal malignancy * Patient refusal to undergo either EUS-RFA or adrenalectomy

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Conditions

The condition(s) this trial relates to.

adrenal cortex adenoma aldosterone-producing adrenal cortex adenoma Cushing syndrome hyperaldosteronism primary aldosteronism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aldosterone-producing adenoma Hypercortisolism Primary aldosteronism

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New Needle-Free treatment could replace surgery for adrenal tumors

What the study statuses mean