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

NCT ID NCT05326230

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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