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Sound waves vs. high blood pressure: new device shows promise

NCT ID NCT05326230

Disease control Sponsor: Otsuka Medical Devices Co., Ltd. Japan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests a device called Paradise™ that uses ultrasound to calm overactive nerves in the kidneys, which can drive high blood pressure. Researchers will compare the device to a sham (fake) procedure in 154 adults with hypertension who are already taking two blood pressure pills. The goal is to see if the treatment safely lowers blood pressure more than the sham procedure.

What this could mean

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

Active substance
Ultrasound renal denervation device (Paradise™ PRDS-001)
What this could lead to
If it works, this could offer a new, drug-free way to lower blood pressure for people whose hypertension is not well controlled with medication.
What could go wrong
This is an early-stage study with only 154 participants, so results may not apply to everyone. The procedure involves risks like blood vessel damage, and the blood pressure reduction may be modest or not last long.

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 154 people

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

Started

Jul 2022

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 to 75 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 : * Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage. * Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit. * Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit Exclusion Criteria * Lacks appropriate renal artery anatomy for renal denervation * Secondary hypertension other than sleep apnea * Type 1 diabetes mellitus or uncontrolled Type 2 diabetes * Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent * Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent * Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health * Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period * Patients with a history of persistent or permanent atrial tachyarrhythmia * Patients with active implantable medical devices * Primary pulmonary hypertension * Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media * Night shift workers * Pregnant, nursing or planning to become pregnant * Patients with any of the following central laboratory tests at screening * Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml * HbA1c greater than or equal to 8.0% * eGFR less than 40 mL/min/1.73m2

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hypertensive disorder vascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Hypertension Vascular diseases

Contacts and locations

Locations

  • Chikamori Hospital

    Kochi, Kochi, Japan

  • Chuno Kousei Hospital

    Seki-shi, Gifu, Japan

  • Ehime University Hospital

    Toon-shi, Ehime, Japan

  • Fukuoka Sanno Hospital

    Fukuoka, Fukuoka, Japan

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, Japan

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, Japan

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, Japan

  • Hiroshima City North Medical Center Asa Citizens Hospital

    Hiroshima, Hiroshima, Japan

  • Imamura Hospital

    Tosu-shi, Saga-ken, Japan

  • Iwaki City Medical Center

    Iwaki, Fukushima, Japan

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, Japan

  • Japanese Red Cross Musashino Hospital

    Musashino-shi, Tokyo, Japan

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, Japan

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, Japan

  • Kimura Clinic

    Meguro-Ku, Tokyo, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, Japan

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, Japan

  • Kurume University Hospital

    Kurume-shi, Fukuoka, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, Japan

  • Minamino Junkanki Hospital

    Hachioji-shi, Tokyo, Japan

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo, Japan

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, Japan

  • National Cerebral and Cardiovascular Center

    Suita-shi, Osaka, Japan

  • Nayoro City General Hospital

    Nayoro-shi, Hokkaido, Japan

  • Nihonkai General Hospital

    Sakata-shi, Yamagata, Japan

  • Niigata City General Hospital

    Niigata, Niigata, Japan

  • Nishinomiya Municipal Central Hospital

    Nishinomiya-Shi, Hyōgo, Japan

  • Nissan Tamagawa Hospital

    Setagaya-ku, Tokyo, Japan

  • Okayama Rosai Hospital

    Okayama, Okayama-ken, Japan

  • Osaka Rosai Hospital

    Sakai-shi, Osaka, Japan

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, Osaka, Japan

  • Osaka University Hospital

    Suita-shi, Osaka, Japan

  • Ryukyu University Hospital

    Naha, Okinawa, Japan

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa, Japan

  • Sanin Rosai Hospital

    Yonago-shi, Tottori, Japan

  • Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, Japan

  • St. Luke's International Hospital

    Cyuo-ku, Tokyo, Japan

  • Suzuka Chuo General Hospital

    Suzuka-Shi, Mie-ken, Japan

  • Toho University Medical Center Ohashi Hospital

    Meguro-ku, Tokyo, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, Japan

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu-shi, Chiba, Japan

  • Tokyo Rosai Hospital

    Ōta-ku, Tokyo, Japan

  • Tokyo Saiseikai Central Hospital

    Minato-ku, Tokyo, Japan

  • Tokyo Takanawa Hospital

    Minato-ku, Tokyo, Japan

  • Tomakomai City Hospital

    Tomakomai-shi, Hokkaido, Japan

  • Tonan Hospital

    Sapporo, Hokkaido, Japan

  • Toranomon Hospital

    Minato-ku, Tokyo, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, Japan

  • Yokohama City University Hospital

    Yokohama, Kanagawa, Japan

  • Yokohama Rosai Hospital

    Yokohama, Kanagawa, Japan

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