A friend asked me to weigh in on this and here is my response:
Here goes: ALERT- need more study detail to thoroughly weigh in, BUT:
This is a study to determine if there is any leakage from the barrier. My assumption is that there is reasonable preclinical and in vitro testing to be able to make this a reasonable hypothesis that it would prevent the risk of peritoneal seeding (but I am not familiar with the testing that supports this so just an assumption). The study appears to be planned for women without any findings suspicious for cancer (hear me out…) so the risk is 1/396 for unsuspected cancer. If additional precautions are required for the inclusion criteria (which I suspect they are-but do not have that level of detail available without looking at the protocol itself), the risk would be even lower (examples would be broader imaging like MRI of the abdomen and pelvis, or sequential ultrasound surveillance, fibroid characteristics that would make it much less likely to be leiomyosarcoma, younger age (age was a significant risk factor), all combined with. preoperative endometrial biopsy (frozen section has more risk of a false negative than traditional biopsy pathology), etc…). In addition, I am certain the informed consent would be transparent about the risks of uterine morcellation. There are certainly real advantages to minimally invasive procedures so there are potential downstream advantages to developing safe methods for appropriate cases. Lastly, it is important to evaluate the prognosis of these undiagnosed cancers before a traditional hysterectomy to weigh in on the risks of morcellation (stage I/II leiomyosarcoma has a significant 5-year mortality rate-I hate that DAMN EVIL cancer). The argument in the article that this would have to be studied in women with uterine cancer is actually the study that, until reassuring additional safety is established with the barrier device, could not be done ethically. If I understood the risk to be 1/~400 of an undiagnosed cancer and that is further decreased by certain factors (premenopausal, biopsy, single fibroid, sequential US showing no rapidly growing pathology, etc…), I would consider participating to allow an opportunity to have a laparoscopic procedure, less risk of needing a transfusion, quicker recovery, and shorter hospital stay. I would need the whole story from both sides to truly weigh in but understand there are appropriate ways to mitigate risks. I have seen a high ethical standard applied to research at UNC and am confident these physicians would not jeopardize patient safety. It deserves further information gathering before shedding judgment is where I have landed following brief/ superficial research into it combined with my clinical OB/Gyn and research experience. Ready for a bash session but the right answer will reside in the detail.
