Health TrialsbyHealthPanel

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

ConditionsSarcoma, EwingChondrosarcomaOsteosarcomaFibrous HistiocytomaFibrosarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorRicoh USA, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must be at least 13 years of age.

Subjects must have the ability to provide written informed consent.

Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.

Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Disqualifiers

Pregnant or nursing women.

Subjects that have a serious systemic pathology.

Subjects that have clotting disorders.

Subjects that have uncontrolled hypertension.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D Printed Anatomic Model

    Device

    Patient-specific 3D printed anatomic model for pre-surgical planning

  • CT/MRI

    Diagnostic test

    Standard imaging type for bony tumors

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Standard ImagingActive comparator 1 intervention
Group B: 3D Printed Anatomic ModelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Operative time

Operative time of surgical procedure based on incision and closure time

Time frame
Incision to closure

Secondary outcomes

1

Blood loss

Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.

Time frame
Incision to closure
2

Adverse Events

The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.

Time frame
Surgery to 90 days post-surgery
3

Tumor margin status

The proportion of negative tumor margins as determined by laboratory analysis.

Time frame
Post-surgery (+3 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ricoh USA, Inc.

Lead sponsor

Source ClinicalTrials.gov
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