Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-18

Brief Summary

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The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:

* Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
* Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture.

Participants will:

* Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
* The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
* The images of CBCT will be collected

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Detailed Description

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Conditions

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Lung Nodules

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GPS guided lung puncture

Participants will receive percutaneous lung puncture under the guidance of GPS.

Group Type EXPERIMENTAL

Generative AI Based Puncture Surgery Navigation System

Intervention Type COMBINATION_PRODUCT

Participants will receive percutaneous lung puncture under the guidance of GPS.

CBCT guided lung puncture

Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

Group Type PLACEBO_COMPARATOR

Cone beam CT

Intervention Type DEVICE

Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

Interventions

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Generative AI Based Puncture Surgery Navigation System

Participants will receive percutaneous lung puncture under the guidance of GPS.

Intervention Type COMBINATION_PRODUCT

Cone beam CT

Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
* Participants with pre-operation CT images available.
* Participants whose physical condition is suitable for PLP.

Exclusion Criteria

* Participants have metallic implants in the body, which severely affects the image quality.
* Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
* Participants are pregnant or breastfeeding.
* Participants are unwilling or unable to sign informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No