Participation in Clinical Trials
In recognition for their expertise and interest in pelvic organ prolapse surgery, Associate Professor Alan Lam’s Centre for Advanced Reproductive Endosurgery (CARE) Lam was invited to participate in the multicentre international Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study.
Brief summary
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
Trial website
Trial Ethics Approval:
- Our Centre CARE received authorisation from St Vincent’s Hospital Research Office on 23 March 2017.
- SVH File Number:16/216
- HREC reference number: HREC/16/SVH/304
- https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=6243&isClinicalTrial=True
Study type:
- Observational
Personnel at CARE authorised to participate in study activities:
- Alan Lam – Principal investigator
- Jessica Lowe – sub-investigator and independent POP-Q evaluator
- Valerie To- sub-investigator and independent POP-Q evaluator
- Julie Hiser – research co-ordinator