Clinical Evaluation Summary
Early in 2007, Innovamed initiated a worldwide clinical evaluation of the Laprostop® device to gather feedback and opinions from prominent laparoscopic surgeons. Seventeen laparoscopic surgeons in nine different countries received Laprostops to test during laparoscopic surgeries. These countries included eight locations in the United States, along with Russia, Australia, Germany, Belgium, Italy, France, Switzerland and South Africa. All the surgeon participants specialize in obstetrics and gynecology, gynecologic oncology, or infertility. The surgeons were asked to fill in a survey form for each procedure in which the Laprostop was used. The survey forms were designed to capture the surgeons' feedback, and included the following:
- Name, date, and type of procedure, diagnosis, procedure time
- Patient profile (age, height, weight, previous surgeries)
- Physician profile (specialty, experience, role in procedure)
- Trocar data (size, location, brand, type) for main port and accessory trocars
- Laprostop data (distance from tip to base, sutured or not, slippage or not)
- Complications (yes or no, related to device or not)
- Ease of use (rate 1-3, number of times used)
- Additional comments
The clinical evaluation is continuing until the fall of 2007, and results are still being compiled. A preliminary look at 92 survey forms completed from April through July 2007 yielded the following feedback:
- Among the 92 patients, the average age was 34.
- The average time of the procedure was 70 minutes.
- The surgeons used an average of 3 trocars during the procedure.
- For 25 of the 92 cases, the Laprostop was sutured into place (27%).
- The Laprostop device was not related to any noted complications.
- For 76% of the cases, the surgeon indicated the Laprostop was "very easy to use", and for the remaining 24%, it was deemed "moderately easy to use."
There were very positive comments from the surgeons about the Laprostop's performance. Among those commenting, the surgeons thought the Laprostop "worked very well", "gave good stability", "stopped the progression of the trocar" and it helped the trocar "stay in place without repositioning." In addition, another surgeon thought that suturing in the Laprostop "works well in these long surgeries", and especially when the trocars are "used to change instruments often."
As the clinical evaluation results continue to arrive, Innovamed will update this summary and share the results at our website.