Thin EBUS Pilot Study

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

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-09

Study Completion Date

2024-09-28

Brief Summary

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This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.

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Detailed Description

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Conditions

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Lung; Node

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Procedural group

Slimscope

Intervention Type DEVICE

Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.

Interventions

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Slimscope

Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to provide informed consent.
2. \>21 years of age or older.
3. Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically.
4. Target lesion(s) location documented on CT scan report.
5. Indicated for bronchosocpy.
6. Bronchoscopic procedure scheduled within 30 days of the CT scan report.

Exclusion Criteria

1. Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
2. Currently on anticoagulation medications with INR \>1.5.
3. Currently using DOAC and does not suspend use at least 7 days prior to the index procedure
4. Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No