University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 mm.
“It’s itty bitty,” she said in a news release. “You just couldn’t have fabricated something like this, even six, seven years ago.”
Dr. John Heusinkveld has used the falloposcope since September to look inside the fallopian tubes of four volunteers who were having their tubes removed for non-cancer reasons.
“This is the first endoscope that can fit inside a fallopian tube and actually see anything below the surface with high resolution,” said Heusinkveld, who is an assistant professor of obstetrics and gynecology at the College of Medicine – Tucson and a board-certified specialist in female pelvic medicine and reconstructive surgery at the Banner – University Medical Center in Tucson.
The 20-patient pilot trial will allow the researchers to test the device’s effectiveness and understand what non-cancerous tubes look like for comparison, with Heusinkveld offering ease-of-use and effectiveness feedback to the engineering team.
“The goal here is to show that we can get into the fallopian tubes – which is nontrivial itself – take images, assess the quality of the images and get physician feedback,” Barton said. “This study will help establish a baseline of the range of what ‘normal’ looks like.”
How Barton’s falloposcope works
Barton’s falloposcope device examines metabolic and functional changes in tissue with fluorescence imaging, structural changes with optical coherence tomography, and collects further tissue information with white light reflectance imaging.
Barton has spent nearly a decade on the device. The U.S. Army has funded its clinical development since 2018.
The device’s FDA approval and availability is not expected for several years. Barton is working with the university’s Tech Launch Arizona on commercialization strategies.
The human impactThe team hopes to use the device in patients with a high cancer risk to not only catch early-stage cancer, but also to avoid unnecessary preventative removal of the tubes.
More than half of women diagnosed with ovarian cancer die within five years of diagnosis because most cases evade detection until advanced stages. If the new falloposcope can detect cancer sooner, surgeons can remove the ovaries and fallopian tubes (with prophylactic salpingo-oophorectomies) before the cancer spreads.
Ovarian cancer is believed to usually start in the fallopian tubes, so at-risk women may opt for preventative removal despite the side effects of surgically induced menopause.
In one study, Barton said, 122 at-risk women had their tubes removed, but a look at the removed tubes showed only seven were developing cancer.
“This device could allow us to tell those other 115 women, ‘Hey, you are perfectly normal, and we’ll come back and check on you every couple of years to make sure everything is OK,” Barton said.