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Search / Trial NCT04322747

Hearing Changes After Surgery

Launched by GATEWAY BIOTECHNOLOGY, INC. · Mar 24, 2020

Trial Information

Current as of August 02, 2025

Withdrawn

Keywords

Hearing Changes Non Surgical Ear Hearing Loss Vibration Exposure Skull Based Surgery Un Operated Ear

ClinConnect Summary

High-speed drills that are capable of producing elevated levels are used during skull based surgeries (Hilmi et al., 2011; Yu et al., 2014). Recently, it has been shown that surgical drilling may have a temporary effect on the amplitude of the otoacoustic emissions of the ear contralateral to the surgical site (Baradaranfar et al., 2015; Shenoy et al., 2015), however the temporary effects of surgical noise or vibration on the hearing of the non-surgical related ear needs to be better quantified. This study aims to to measure the potential effects of surgical drilling noise and/or vibration ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • participants are undergoing a skull-based or mastoid surgery for treatment of an affected ear
  • participants have normal or near-normal hearing thresholds in the un-operated ear
  • Exclusion Criteria:
  • participants have hearing loss (PTA \> 40 dB HL) in pure tone audiometry testing before surgery in the un-operated ear
  • participants have medical conditions after the surgery which prevents having hearing tests
  • participants have abnormal tympanometric results

About Gateway Biotechnology, Inc.

Gateway Biotechnology, Inc. is a pioneering clinical trial sponsor dedicated to advancing innovative therapeutic solutions through rigorous research and development. With a focus on biotechnology and pharmaceutical advancements, the company is committed to conducting high-quality clinical trials that prioritize patient safety and scientific integrity. Leveraging a team of experienced professionals and cutting-edge technology, Gateway Biotechnology aims to facilitate the efficient progression of novel treatments from the laboratory to the clinic, ultimately improving patient outcomes and contributing to the advancement of healthcare.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Partha Thirumala, MD

Principal Investigator

University of Pittsburgh Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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