NCT02525666 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Donovan JL, Peters TJ, Abrams P, Brookes ST, de aa Rosette JJ, Schäfer W
Scoring the short form ICSmaleSF questionnaire. International Continence Society. J Urol. 2000 Dec;164(6):1948-55.
Poelman MM, van den Heuvel B, Deelder JD, Abis GS, Beudeker N, Bittner RR, Campanelli G, van Dam D, Dwars BJ, Eker HH, Fingerhut A, Khatkov I, Koeckerling F, Kukleta JF, Miserez M, Montgomery A, Munoz Brands RM, Morales Conde S, Muysoms FE, Soltes M, Tromp W, Yavuz Y, Bonjer HJ
EAES Consensus Development Conference on endoscopic repair of groin hernias. Surg Endosc. 2013 Oct;27(10):3505-19. doi: 10.1007/s00464-013-3001-9. Epub 2013 May 25.
Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M
European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.
Tam KW, Liang HH, Chai CY
Outcomes of staple fixation of mesh versus nonfixation in laparoscopic total extraperitoneal inguinal repair: a meta-analysis of randomized controlled trials. World J Surg. 2010 Dec;34(12):3065-74. doi: 10.1007/s00268-010-0760-5.

Evaluation of Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM) in a Prospective Cohort Study

Clinical trial NCT02525666 - References