Status:

COMPLETED

Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

Lead Sponsor:

Shanghai Chest Hospital

Conditions:

Lung Cancer

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resectio...

Eligibility Criteria

Inclusion

  • Age between 18 and 80 years inclusive;
  • No distant metastasis in preoperative clinical assessment;
  • The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
  • Target lung nodule diameter is no more than 2 cm;
  • The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
  • Non-pleural surface nodules;
  • Preoperative ECOG performance status score of 0/1;
  • Voluntarily participating in this study and signing an informed consent form.

Exclusion

  • More than two lung nodules need to be removed at the same time.
  • The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
  • Patients with chronic pain issues or those who have been taking pain medications for an extended period.
  • Patients have uncontrollable mental illness and cannot make subjective assessment.

Key Trial Info

Start Date :

August 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2025

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT06548451

Start Date

August 15 2024

End Date

September 30 2025

Last Update

November 28 2025

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 200030

2

Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200030

3

the people's second hospital Hefei

Hefei, China

4

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, China

Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial | DecenTrialz