NCT02966847

Brief Summary

In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

November 15, 2016

Last Update Submit

May 22, 2023

Conditions

Thoracoscopy

Keywords

Video assisted thoracoscopyCone beam computed tomography

Outcome Measures

Primary Outcomes (1)

  • Assessment of CBCT

    Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.

    the day following the acquisition

Secondary Outcomes (3)

  • Feasibility of CBCT

    At the end of the surgery

  • Assessment of global image quality

    the day following the acquisition

  • Assessment of image quality of lesions

    the day following the acquisition

Study Arms (1)

CBCT Acquisition

EXPERIMENTAL

The anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars.

Procedure: CBCT acquisitionProcedure: Anesthesia and surgery

Interventions

CBCT acquisitionPROCEDURE

Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device

Also known as: Artis Zeego System®
CBCT Acquisition
Anesthesia and surgeryPROCEDURE

The anesthesia and surgery will take place according clinical routine practice

CBCT Acquisition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18;
  • patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
  • Complete preoperative assessment;
  • Patient receiving information about the protocol who did not indicate his/her opposition to participate;
  • Patient covered by a social insurance system

You may not qualify if:

  • Reoperation (history of ipsilateral thoracic surgery);
  • Inability to achieve or obtain a single-lung ventilation during surgery;
  • Adult subject to legal protection (trusteeship, guardianship);
  • Person deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de RENNES

Rennes, 35033, France

Location

Related Publications (1)

  • Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.

    PMID: 33588119RESULT

MeSH Terms

Interventions

AnesthesiaSurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Simon ROUZE, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

May 11, 2017

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)