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NCT06387485 · ClinicalTrials.gov registry record · NA

A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

A NA study of Osteosarcoma and Chondrosarcoma, sponsored by Ricoh USA.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
3
Study locations

NCT06387485 is a NA study of Osteosarcoma and Chondrosarcoma that is actively recruiting participants, run by Ricoh USA. The registered enrollment target is 150 participants, below the 299-participant average among 46 other Osteosarcoma trials with a reported enrollment target (50% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT06387485, a NA study of Osteosarcoma and Chondrosarcoma, is actively recruiting participants, sponsored by Ricoh USA.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
3
Study locations

Study Summary

This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging. Primary endpoint: Operative time of surgical procedure. Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins. Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.

Interventions

  • DEVICE 3D Printed Anatomic Model
  • DIAGNOSTIC_TEST CT/MRI

Study Locations (3)

California

  • Kaiser Permanente Oakland Medical Center - Oakland

Michigan

  • William Beaumont University Hospital - Royal Oak

Ohio

  • The Ohio State University Wexner Medical Center - Columbus

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-03-01
Est. Completion 2027-07-31
Phase NA

Sponsor

Ricoh USA

1 total trials

What the Registry Record Tells You About NCT06387485

The ClinicalTrials.gov registry entry for NCT06387485 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 299-participant average among 46 other Osteosarcoma trials with a reported enrollment target (50% lower). The listed sponsor is Ricoh USA, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 2 interventions - of which 3D Printed Anatomic Model is the first listed.

NCT06387485 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Michigan, Ohio.

Frequently Asked Questions

What is clinical trial NCT06387485 about?

NCT06387485 is a clinical study titled "A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning". This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects a...

What is the current status of trial NCT06387485?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-03-01. Estimated completion is 2027-07-31.

What conditions does trial NCT06387485 study?

This clinical trial studies the following conditions: Osteosarcoma, Chondrosarcoma, Sarcoma, Ewing, Fibrosarcoma, Fibrous Histiocytoma.

What interventions are being tested in trial NCT06387485?

The interventions under investigation include: 3D Printed Anatomic Model (DEVICE), CT/MRI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06387485?

This trial is sponsored by Ricoh USA, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06387485 being conducted?

This trial has 3 study locations across California, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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