- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04809298
Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method (PunctureCube)
Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture Cube® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Luca Remonda, Prof.
- Telefonnummer: +41 62 838 43 21
- E-post: luca.remonda@ksa.ch
Studiesteder
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Aargau
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Aarau, Aargau, Sveits, 5001
- Rekruttering
- Department of Neuroradiology, Kantonsspital Aarau
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Ta kontakt med:
- Luca Remonda, Prof.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients requiring a percutaneous therapeutic CT-guided intervention for
- lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level)
- age ≥ 18 years
- Signed informed consent prior to intervention
Exclusion Criteria:
- Patients suffering from severe obesity (BMI > 30 kg/m2)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Free-hand lumbar punction
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
|
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
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Aktiv komparator: Puncture Cube
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
|
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Puncture accuracy
Tidsramme: during procedure time approximately 30 min.
|
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
|
during procedure time approximately 30 min.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of control acquisitions to achieve target
Tidsramme: during procedure time approximately 30 min.
|
Number of control acquisitions to achieve target
|
during procedure time approximately 30 min.
|
Assessment of radiation dose
Tidsramme: during procedure time approximately 30 min.
|
Assessment of radiation dose
|
during procedure time approximately 30 min.
|
Assessment of intervention time
Tidsramme: during procedure time approximately 30 min.
|
Assessment of intervention time
|
during procedure time approximately 30 min.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Luca Remonda, Prof., Department of Neuroradiology, Kantonsspital Aarau
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Puncture Cube
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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