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

February 13, 2024 updated by: Matthew Kaufman, MD, Advanced Reconstructive Surgery Alliance

A Grounded Theory of Phrenic Nerve Reconstruction for the Treatment of Diaphragm Paralysis - A Biopsychosocial Approach to Surgical Evaluation and Outcomes

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Red Bank, New Jersey, United States, 07701
        • Advanced Reconstructive Surgery Alliance
      • Shrewsbury, New Jersey, United States, 07702
        • Institute for Advanced Reconstruction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age 18 and below.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intrathoracic Approach

Patients who have undergone the intrathoracic approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis.

NO INTERVENTION.
Cervical Approach

Patients who have undergone the cervical approach of phrenic nerve reconstruction for the treatment of diaphragmatic paralysis.

NO INTERVENTION.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Position of Diaphragm.
Time Frame: Up to 12 Months.
Radiographic Thoracic Imaging.
Up to 12 Months.
Pulmonary Function.
Time Frame: Up to 12 Months.
Pulmonary Function Test (PFT).
Up to 12 Months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Reconstructive Surgery Alliance

Investigators

  • Principal Investigator: Matthew Kaufman, MD, Advanced Reconstructive Surgery Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-Phase-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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