What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE

Status Completed

Clinical Trial Summary

Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

Clinical Trial Description

Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants". 14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04902963
Study type	Interventional
Source	Skovlund Medical Products, LLC
Contact
Status	Completed
Phase	N/A
Start date	March 15, 2011
Completion date	November 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04776967` - Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.	N/A
Recruiting	`NCT04804098` - Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.	N/A
Terminated	`NCT01974726` - Gas Supply, Demand and Middle Ear Gas Balance -- Diagnosis of Eustachian Tube Dysfunction	N/A
Recruiting	`NCT05600595` - The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children
Not yet recruiting	`NCT05998356` - Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease	N/A
Not yet recruiting	`NCT03322579` - Balloon Dilation of the Eustachian Tube, a Lower Pressure Challenge	N/A
Withdrawn	`NCT03886740` - Tympanostomy Tubes Versus Eustachian Tube Dilation	N/A
Completed	`NCT04809753` - Eustachian Tube Dilation With an Endovascular Balloon	N/A
Withdrawn	`NCT02631187` - Feasibility Study of Balloon Eustachian Tuboplasty (BET)	N/A
Completed	`NCT04136977` - XprESS ET Registry
Completed	`NCT03197558` - Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)	Phase 2
Recruiting	`NCT05719207` - Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction	N/A
Completed	`NCT01251432` - Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults	N/A
Recruiting	`NCT05055115` - Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis	N/A
Recruiting	`NCT04645511` - Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.	N/A
Not yet recruiting	`NCT05222230` - FFP3 Respirators and Ears - Effects on Middle Ear Pressure and Hearing	N/A
Completed	`NCT02667301` - Eustachian Tube Dysfunction Assessment	N/A
Not yet recruiting	`NCT05229380` - Pretympanoplasty Assessment of Patency and Mucociliary Function of Eustachian Tube
Completed	`NCT03850197` - Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
Terminated	`NCT05270031` - Balloon Dilation of the Eustachian Tube	N/A

What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms