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NCT02952261

Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Completed NA Results posted Last updated 19 December 2018
What this trial tests

NA trial testing template-guided localization in Lung Neoplasm in 200 participants. Completed in 25 October 2017.

Timeline
24 October 2016
Primary endpoint
1 October 2017
25 October 2017

Quick facts

Lead sponsorChang Chen
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date24 October 2016
Primary completion1 October 2017
Estimated completion25 October 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chang Chen — full company profile →

Who can join

Adults 19 to 80, any sex, with Lung Neoplasm or Thoracic Surgery, Video-Assisted. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Lung Nodule Localization Primary · From the time of completing final CT scan, assessed up to 2 days.

Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)

GroupValue95% CI
CT-guided Localization9.6± 5.8
Template-guided Localization8.7± 6.9
Procedural Duration of the Nodule Localization Secondary · From the time of completing final CT scan, assessed up to 1 hour.

Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.

GroupValue95% CI
CT-guided Localization9.5± 3.6
Template-guided Localization7.4± 3.2
Radiation Dose Secondary · From the time of completing final CT scan, assessed up to 1 hour.

Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.

GroupValue95% CI
CT-guided Localization313± 84
Template-guided Localization229± 65
Complication Rate Secondary · From the time of completing final CT scan, assessed up to 2 days.

Pnuemothorax related to lung nodule localization

GroupValue95% CI
CT-guided Localization17
Template-guided Localization10

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CT-guided Localization
Serious: 0/95 (0%)
Deaths: 0/95
Template-guided Localization
Serious: 0/95 (0%)
Deaths: 0/95
Other adverse events (2 terms — click to expand)

ReactionSystemCT-guided LocalizationTemplate-guided Localization
pnueumothoraxSurgical and medical procedures
HemorrhageSurgical and medical procedures

Data from ClinicalTrials.gov NCT02952261 adverse events section.

Sponsor's own description

The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current standards and ethical landscape of engineered tissues-3D bioprinting perspective.
    Sekar MP, Budharaju H, Zennifer A, Sethuraman S, et al · · 2021 · cited 65× · PMID 34377431 · DOI 10.1177/20417314211027677
  2. From ideas to long-term studies: 3D printing clinical trials review.
    Witowski J, Sitkowski M, Zuzak T, Coles-Black J, et al · · 2018 · cited 39× · PMID 29790077 · DOI 10.1007/s11548-018-1793-8
  3. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial.
    Zhang L, Wang L, Kadeer X, Zeyao L, et al · · 2019 · cited 38× · PMID 30586136 · DOI 10.1001/jamasurg.2018.4872

Verify or expand the search:

Other recruiting trials for Lung Neoplasm

Currently open trials in the same condition.

Other Chang Chen trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02952261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing