Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression

NCT ID: NCT06998420

Last Updated: 2025-05-31

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

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-10

Study Completion Date

2025-02-28

Brief Summary

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This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:

1. What factors are associated with adverse postoperative outcomes?
2. What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.

Detailed Description

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Conditions

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Trigeminal Neuralgia (TN)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University
2. Age ≥18 years
3. Willing to complete postoperative follow-up

Exclusion Criteria

1. Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
2. Previous interventional treatments for trigeminal neuralgia
3. Incomplete follow-up data
4. General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2024-K098-01

Identifier Type: -

Identifier Source: org_study_id

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