NCT05170074 - 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)

Levy G, Padoa A, Fekete Z, Bartfai G, Pajor L, Cervigni M
Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J. 2018 May;29(5):709-714. doi: 10.1007/s00192-017-3415-3. Epub 2017 Jul 14.
Levy G, Padoa A, Marcus N, Beck A, Fekete Z, Cervigni M
Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:55-59. doi: 10.1016/j.ejogrb.2020.01.005. Epub 2020 Jan 9.

National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)

Details for clinical trial NCT05170074

Clinical trial NCT05170074 - References