Viewing Study NCT05695404


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Study NCT ID: NCT05695404
Status: COMPLETED
Last Update Posted: 2023-01-25
First Post: 2023-01-02
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Contribution of 3D Printing in Anatomical Lung Segmentectomies.
Sponsor: Institut Mutualiste Montsouris
Organization:

Study Overview

Official Title: Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.
Status: COMPLETED
Status Verified Date: 2023-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: 3DiLUNG
Brief Summary: The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.
Detailed Description: Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

We performed a prospective randomized controlled pilot trial on 2 parallel arms:

* The "Digital" arm
* The "Digital+Object" arm.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: