Clinical Trials

Several completed clinical trials have evaluated biomedical applications of polytetrafluoroethylene, investigating conditions such as gingival pocket retraction, gastrointestinal transit dynamics in irritable bowel syndrome, surgical hernia repair, and stress-influenced wound healing. Because polytetrafluoroethylene functions as a physical biomaterial rather than a systemic therapeutic agent, the trial phases are designated as not applicable or unassigned. Supported by various academic and healthcare sponsors, these studies reflect the material's clinical utility across diverse surgical and interventional procedures.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04087226 Completed
Gingival Pocket
Dow University of Health Sciences
 2019-10-01 Not Applicable
NCT01534507 Completed
Irritable Bowel Syndrome
University of Nottingham
 2011-11 --
NCT01364233 Completed
Hernia
Medline Industries
 2011-05 Not Applicable
NCT00633737 Completed
Wound Healing|Stress|Surgery
University of Auckland New Zealand|Health Research Council New Zealand
 2008-03 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Polytetrafluoroethylene product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Polytetrafluoroethylene functions as an inert biomedical polymer characterized by an exceptionally low coefficient of friction and non-stick physical properties that prevent biological tissue adhesion and mechanical shear at the biomaterial interface. This biophysical barrier reduces localized mechanical trauma, friction, and secondary inflammatory signaling, thereby facilitating stable tissue separation and structural support in clinical applications such as surgical wound healing, hernia repair, and dental procedures.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.