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Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System (CMT-VX)

22 juni 2026 bijgewerkt door: Juin-Hong Cherng

The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System

Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.

The Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.

This post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:

Tri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.

Taoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.

The primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Background and Rationale:

Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.

The Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.

This is a prospective, open-label, randomized, parallel-controlled, non-inferiority clinical trial conducted in Taiwan to evaluate the safety and clinical effectiveness of this system (Model: BVFT-UP01-D20, Approved No. 005889) compared with conventional vertebroplasty performed using manual orthopedic surgical instruments (Approved No. 005698), both manufactured by CMT. Both groups will utilize the same radiopaque bone cement ("Tecres" Osteopal V) for the therapeutic procedures.

Hypothesis:

The study is designed as a non-inferiority trial. The primary hypothesis is that the incidence of unanticipated serious adverse device effects (USADEs) in the Vessel-X® group is not higher than that in the control group. For efficacy, the experimental group is hypothesized to be non-inferior to the control group regarding pain relief, disability improvement, and radiographic parameters, with a pre-specified non-inferiority margin of -15% for the difference in fused effective rates between the two groups.

Patient Enrollment and Site Allocation:

To achieve the clinical evaluation objectives, a total of up to 146 subjects will be recruited across participating medical centers in Taiwan. The target sample size is allocated specifically as 86 subjects from Tri-Service General Hospital (TSGH) and 60 subjects from Taoyuan General Hospital (TYGH). Subjects at each site will be allocated to the experimental and control groups using a 1:1 randomization scheme.

Surgical Procedure Protocol:

All surgical procedures will be performed under real-time fluoroscopic (C-arm) guidance using a standard unilateral transpedicular approach:

Experimental Group: The Vessel-X® PET biocompatible microporous container will be deployed into the vertebral body, and bone cement will be injected in a controlled manner, allowing partial cement interdigitation through the micropores. The container remains as a permanent implant.

Control Group: Conventional vertebroplasty will be performed using CMT's standard manual orthopedic surgical instruments to deliver the bone cement directly.

In both groups, fluoroscopic monitoring is maintained throughout the injection, and cement delivery will be discontinued immediately if any cement leakage or breach is observed.

Clinical Evaluation Timelines:

Subjects will participate in the study for a total duration of 13 months, consisting of a 1-month screening period, the surgical intervention (Day 1), and a 12-month post-operative follow-up period. Follow-up visits are scheduled at Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days).

Outcome Assessments:

Safety Assessment (Primary Endpoint, ITT Population): Evaluated by the incidence of adverse events, complications, bone cement leakage, and new-onset neurological deficits.

Efficacy Assessment (Secondary Endpoints, PP & FAS Populations): Evaluated by changes from baseline to each follow-up timepoint in Visual Analogue Scale (VAS) scores for pain, Oswestry Disability Index (ODI) scores for functional disability, and radiographic parameters (anterior vertebral height, midline vertebral height, and kyphotic Cobb's angle)

Studietype

Ingrijpend

Inschrijving (Geschat)

146

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Juin-Hong Cherng, Ph.D.
  • Telefoonnummer: 18681, 18699 886-2-87923100
  • E-mail: i72bbb@gmail.com

Studie Contact Back-up

  • Naam: Gang-Yi Fan, Ph.D.
  • Telefoonnummer: 18699 886-2-87923100
  • E-mail: u9310318@gmail.com

Studie Locaties

  • Taiwan
      • Taipei, Taiwan, 114202
        • Werving
        • Tri-Service General Hospital, National Defense Medical Univesity
        • Contact:
        • Contact:
          • Juin-Hong Cherng, Ph.D.
          • Telefoonnummer: 18698, 18699 886-2-87923100
          • E-mail: i72bbb@gmail.com
      • Taipei, Taiwan, 11490
        • Werving
        • National Defense Medical University, Taiwan
        • Contact:
        • Contact:
          • Juin-Hong Cherng, Ph.D.
          • Telefoonnummer: 18698, 18699 886-2-8792-3100
          • E-mail: i72bbb@gmail.com
        • Hoofdonderzoeker:
          • Chih-Chern Wang, Ph.D.
        • Hoofdonderzoeker:
          • Yu-Hsu Chen, Ph.D.
        • Onderonderzoeker:
          • Yi-Chou Chen, Ｍ.D.
        • Onderonderzoeker:
          • Chien-Ning Hsu, Ｍ.D.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CMT Vessel-X ® Bone Filling Container System
Subjects undergo percutaneous vertebral augmentation using the CMT Vessel-X® Bone Filling Container System (Model: BVFT-UP01-D20). Under fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body. The microporous PET Vessel-X® Bone Filling Container is deployed within the vertebral body and subsequently filled with TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) to stabilize the vertebral compression fracture.
Apparaat: CMT Vessel-X® Bone Filling Container System

Model: BVFT-UP01-D20 (TFDA No. 005889, GMP0106), manufactured by Central Medical Technologies Inc. (marketed since Aug 2017). An EO-sterilized, single-use, implantable kit for percutaneous vertebral augmentation (store <= 25°C, shelf-life: 5 years). The kit includes:

  1. Vessel-X® Bone Filling Container (Model: BVFX-D20): An implantable, microporous PET container to enclose cement and minimize leakage.
  2. Front-Opening Cement Injection Device with Extension Tube (Model: T-C308, max 20 ml): For controlled hydraulic delivery.

  3. Percutaneous Access Tools: Includes 1pc Bone Access Needle (T-N201T), 1pc Guide Pin (T-P602), and 1pc Precision Drill (T-D401).

    • Intervention Cement: TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888), used during vertebral augmentation procedures for injection into the affected vertebra to stabilize vertebral compression fractures.
Actieve vergelijker: CMT Conventional Vertebroplasty
Subjects undergo percutaneous vertebroplasty using the CMT Manual Orthopedic Surgical Instruments (Model: T-C308). Under real-time fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body, and TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) is directly injected into the vertebral body to stabilize the vertebral compression fracture.
Apparaat: CMT Manual Orthopedic Surgical Instruments
The CMT Manual Orthopedic Surgical Instruments (Model: T-C308; TFDA License No. 005698) are nonimplantable manual surgical instruments intended for conventional vertebroplasty procedures. The device functions as a manual cement delivery system for the injection of TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888) into the vertebral body to stabilize vertebral compression fractures.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Adverse Events, Serious Adverse Events (SAEs), and Unanticipated Serious Adverse Device Effects (USADEs)
Tijdsspanne: Day 1 (post-op), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
The primary safety endpoint is to evaluate the safety profile of the "Central Medical" Vessel-X® Bone Filling Container System. Safety assessments will analyze the incidence, specific manifestations, severity, and device-causality of all adverse events (AEs), serious adverse events (SAEs), and unanticipated serious adverse device effects (USADEs) following percutaneous vertebroplasty (including bone cement leakage, nerve root injury, vascular injury, or subsequent vertebral collapse). Proportions of abnormal post-operative cases and complication incidence with 95% Confidence Intervals (CI) will be calculated using the Intent-to-Treat (ITT) population.
Day 1 (post-op), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Visual Analogue Scale (VAS) Pain Score
Tijdsspanne: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Pain intensity will be assessed using the 100-mm Visual Analogue Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. Changes from baseline in VAS scores will be compared between the experimental and control groups to evaluate pain relief following treatment.
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Change From Baseline in Oswestry Disability Index (ODI) Score
Tijdsspanne: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Functional disability will be evaluated using the Oswestry Disability Index (ODI) questionnaire. Changes from baseline in ODI scores will be compared between the experimental and control groups to assess functional recovery following treatment.
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Change From Baseline in Radiographic Anterior Vertebral Height
Tijdsspanne: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Radiographic assessment of anterior vertebral height (measured in millimeters) will be performed using X-ray, computed tomography (CT), or magnetic resonance imaging (MRI). Changes from baseline will be compared between the experimental and control groups to evaluate vertebral body restoration.
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
hange From Baseline in Radiographic Mid-Vertebral Height
Tijdsspanne: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Radiographic assessment of mid-vertebral height (measured in millimeters) will be performed using X-ray, computed tomography (CT), or magnetic resonance imaging (MRI). Changes from baseline will be compared between the experimental and control groups to evaluate vertebral body restoration.
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Change From Baseline in Kyphotic Cobb's Angle
Tijdsspanne: Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.
Radiographic assessment of the kyphotic Cobb's angle (measured in degrees) will be performed using sagittal X-ray, computed tomography (CT), or magnetic resonance imaging (MRI) to evaluate spinal alignment correction. Changes from baseline will be compared between the experimental and control groups.
Baseline (within 1 week pre-operatively), Day 1 (post-operatively), Day 8 (8±2 days), Month 1 (31±2 days), Month 3 (91±15 days), Month 6 (181±15 days), Month 9 (271±15 days), and Month 12 (361±15 days) post-operatively.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Juin-Hong Cherng

Medewerkers

Tri-Service General Hospital
Taoyuan General Hospital

Onderzoekers

  • Hoofdonderzoeker: Dr. Chih-Chien Wang, Ph.D., Trial-Service General Hospital, National Defense Medical University
  • Hoofdonderzoeker: Yu-Hsu Chen, Ph.D., Taoyuan General Hospital, Ministry of Health and Welfare

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 april 2021

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

3 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CMT-BVFT 2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

IPD will not be shared to protect participant privacy and comply with institutional review board (IRB) restrictions and local data protection regulations.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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