MedTrace Logo

Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery

NCT05808140 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-19

No results posted yet for this study

Summary

In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary.

In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots.

The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.

Conditions

  • Disc Herniation

Interventions

DRUG

Indocyanine Green

Preoperatively, a single dose of intravenous indocyanine green is administered

DEVICE

Fluorescence imaging

Use of a spinal endoscopic fluorescent imaging system to assist surgeons in identifying and protecting nerve roots intraoperatively

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Yuanlong Xie, M.D. · Department of Spine Surgery and Musculoskeletal Tumor, Zhongnan Hospital of Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2025-12-14
Completion
2025-12-14

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808140 on ClinicalTrials.gov