CompletedNot Applicable

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

United States444 participantsStarted 2011-06

Plain-language summary

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scheduled for an open thoracotomy for lung resection * Has at least one or more intraoperative visible air leak \>= 2 mm following the lung resection surgery Exclusion Criteria: * Pregnant or breast feeding * History of an allergic reaction to Human Serum Albumin * Has a significant clinical disease or condition * Had previous open thoracotomy procedures * Unable to participate in all necessary study activities due to physical or mental limitations

What they're measuring

Safety Endpoints

Timeframe: 90 days

Trial details

NCT IDNCT01394978

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2017-04-17

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