While the bunionectomy is the gold standard for acute pain experiments in boney surgery, for many years there was no soft tissue equivalent to a bunionectomy (a rapidly recruiting, reliable, experimental soft tissue model with good assay sensitivity). Mindful of this experimental gap and market need, Lotus Clinical Research developed and validated the abdominoplasty model after years of study and pilot work.
For abdominoplasty trials, Lotus Clinical Research provides both site and CRO services. Not only can we perform single-center abdominoplasty studies within our own walls, but we also utilize a network of four well-vetted sites throughout the country for multicenter investigations.
The key to success in abdominoplasty research is minimization of variability and placebo response. To accomplish this, our CRO and sites utilize the Lotus Clinical Research subject placebo response education toolkit. This toolkit has been successfully deployed when our organization serves as a single abdominoplasty center and/or in multicenter abdominoplasty trials in which Lotus Clinical Research serves as the CRO.
The abdominoplasty model has attributes that make it a superior choice to other soft tissue models (such as laparoscopic cholecystectomy, hysterectomy, and herniorrhaphy), namely:
Average enrollment is 40 subjects per month at the Lotus Clinical Research site. Screen failure rates average from 15-20% based on specific inclusion/exclusion criteria and the surgeon’s assessment.
| Phase | Sponsor | Enrolled by Lotus | Total Study N | Clinical Trials.gov No |
|---|---|---|---|---|
| 2 | Trevena | 200 | 200 | NCT02335294 |
| 3 | AcelRx | 47 | 102 | NCT02356588 |
| 3 | Grifols | 40 | 120 | NCT01731938 |
| 3 | Grifols | 9 | 120 | NCT01731938 |
| Phase | Indication | Sponsor | Pts per month Lotus* | Pts per month Non-Lotus* | Comments | ClinicalTrials.gov Identifier |
|---|---|---|---|---|---|---|
| 2 | Vascular | Zymogenetics | 7 | 1 | Top Enroller | Predates CTG |
| 1/2 | Spinal | Zymogenetics | 12 | 2 | Top Enroller | Predates CTG |
| 3 | Spinal/ Vascular | Zymogenetics | 10.2 | 1.8 | Top Enroller | NCT00245336 |
| 3b | Spinal/ Vascular | Zymogenetics | 7 | 0.6 | Top Enroller | NCT00491608 |
| 4 | Liver Surgery | Zymogenetics | 4.5 | N/A | Single Center, IIT | Not Registered |
| 4 | Vascular | King/Pfizer | 16.3 | 1.3 | Top Enroller | NCT00775398 |
| 2 | Spinal/ Vascular/ Soft Tissue ProFibr | ProFibrix | 4.2 | 0.5 | Top Enroller | NCT01256164 |
| 3 | Spinal | ProFibrix | 3 | 1.4 | Top Enroller | NCT01527357 |
| 3 | Vascular/Soft Tissue | ProFibrix | 24 | 1.5 | Top Enroller | NCT01527357 |
*Each clinical trail has its own enrollment challenges therefore, the only way to judge a site’s enrollment is to compare it to other research sites that performed the same study concurrently. Therefore, Lotus tabulates its enrollment performance at the end of each study in the following way: (1) the number of patients enrolled by Lotus is divided by the number of months of active enrollment to generate a patient-per-month figure. (2) the number of patients enrolled by all other centers over the open enrollment period is calculated (x). That number (x) is then divided by the number of months of open enrollment and then again by the number of non-Lotus sites to generate an average non-Lotus site patient-per-month figure. In this way an “apples to apples” comparison can be made; and isn’t that what we are all striving for?
