A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis

Active, not recruiting

• Conditions: Diaphragm Issues; Diaphragmatic Paralysis; Diaphragm; Paralysis, Due to Accidental Section of Phrenic Nerve During Procedure; Breath Shortness

• Registration Number: NCT06257589
• Lead Sponsor: Advanced Reconstructive Surgery Alliance

Brief Summary

A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2024-01-17
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Primary Completion: 2025-10-10
• Study Completion: 2026-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Exclusion Criteria

• Age 18 and below.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary Function.	Up to 12 Months.	Pulmonary Function Test (PFT).
Radiographic Position of Diaphragm.	Up to 12 Months.	Radiographic Thoracic Imaging.

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life (HRQoL).	Up to 12 Months.	SF-36 / RAND Survey.
Safety of Phrenic Nerve Reconstruction for Diaphragmatic Paralysis.	Up to 24 Months.	AEs related to the procedure reported in the medical chart.

Trial Locations

Locations (2)

Institute for Advanced Reconstruction; 🇺🇸 Shrewsbury, New Jersey, United States

Advanced Reconstructive Surgery Alliance; 🇺🇸 Red Bank, New Jersey, United States