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New container device aims to make spinal fracture repair safer

NCT ID NCT07665424

Disease control Sponsor: Juin-Hong Cherng Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called Vessel-X® that uses a special container to deliver bone cement into fractured vertebrae caused by osteoporosis. The goal is to reduce cement leakage and improve safety compared to standard procedures. About 146 adults aged 40 to 95 with spinal fractures will be enrolled at two hospitals in Taiwan. The trial will measure safety, pain relief, and functional recovery.

What this could mean

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

Active substance
Vessel-X® Bone Filling Container System (implantable device for bone cement delivery)
What this could lead to
If successful, this device could offer a safer way to treat spinal fractures by reducing cement leakage, potentially leading to better pain relief and recovery.
What could go wrong
This is a post-market study with 146 participants, so it is not a large-scale trial. The device may not significantly outperform standard procedures, and risks like cement leakage or nerve injury still exist.

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 146 people

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

Started

Apr 2021

Expected to finish

Dec 2026

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

40 to 95 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: Subjects must meet all of the following criteria to be eligible for enrollment in this study: 1. Male or female subjects aged ≥40 and ≤95 years. 2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma. 3. Surgical site within the range of T6 to L5. 4. Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation. 5. Subjects willing to comply with the study schedule and all required assessment procedures. 6. Subjects who are conscious, cognitively intact, and able to provide written informed consent. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study: 1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases. 2. Active or severe systemic infections. 3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism. 4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders. 5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications. 6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant. 7. Active infection at or adjacent to the surgical site. 8. Acute spinal instability. 9. Unwillingness or inability to restrict physical activity or comply with medical instructions. 10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.

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Conditions

The condition(s) this trial relates to.

osteoporosis

As listed by the trial registrant

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

Osteoporosis Osteoporotic vertebral compression fractures

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • National Defense Medical University, Taiwan

    RECRUITING

    Taipei, 11490, Taiwan

  • Tri-Service General Hospital, National Defense Medical Univesity

    RECRUITING

    Taipei, 114202, Taiwan

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