In December of 2021, Italia DeLeon was nearing the end of her second trimester. She and her husband David, who had known each other since they were 13, were looking forward to the arrival of their second son. They planned to name him Diego.
Italia and David are longtime residents of Santa Cruz, California – David was born there, Italia has lived there for over 30 years. David works for a local nonprofit, providing weatherization services for low-income families. Italia spent 12 years working in education before becoming a full-time mom.
Just before New Year’s, Italia started feeling unwell, with an upset stomach and pain in her abdomen. It was reminiscent of her first pregnancy, when she’d had gallstones, but she had since had her gallbladder removed. It was pouring rain outside, but she and David decided to head to urgent care. “We just wanted to make sure everything was okay,” she said.
HELLP
Everything was not okay. Italia’s bloodwork showed that she had HELLP syndrome, a life-threatening pregnancy complication marked by high blood pressure, elevated liver enzymes, and low platelets. To save her life and Diego’s, she would have to deliver as soon as possible. She was 27 weeks pregnant.
“I’d never even heard of HELLP before,” said Italia. “No one in my family had.” The information started coming fast. “They said they had to get me to Stanford, and they started me on steroids because the baby had to come out in a couple of days at most,” she said. The weather made it too dangerous to go by helicopter, so Italia, her mom, and David sped to Lucile Packard Children’s Hospital (LPCH) by ambulance. “There was just so much happening at once,” Italia said. “There were so many unknowns, and it was also hard on our seven-year old – in his mind, one day I was fine and the next day I was in the hospital.”
At LPCH, Italia underwent an emergency c-section. “It was night and day compared to my first delivery,” said Italia. “With my first son, I had a natural birth without even an epidural. This time I couldn’t even hold Diego after he was born.”
Within a few days, Italia was discharged, but Diego stayed in the Neonatal Intensive Care Unit (NICU). She and David started making the long drive to Palo Alto every other day. In between, they stayed in touch with the nurses by phone. “We were trying to visit Diego as much as we could, but it was really challenging trying to balance spending time with our older son and being there for Diego as well,” Italia recalled.
He’s not doing well
When Diego was three weeks old, the DeLeons got a call from the nurses. “We had planned to visit that day, but they told us we needed to get to the hospital immediately,” said David. “We raced out the door, and when we finally arrived, one of the nurses was so distraught over Diego’s condition that she was in tears. ‘What we’re doing isn’t working,’ she said. ‘He’s not doing well.’”
Since birth they had been struggling to get Diego to take pumped breast milk, but it had been an uphill battle with even the smallest feedings. Now his belly was bloated, and the doctors suspected the worst; necrotizing enterocolitis or NEC.
NEC is a gastrointestinal disease in which infection and inflammation cause the intestinal tissue to die. It affects almost 10% of premature infants in the NICU and has a mortality rate as high as 50%.
The DeLeons met with a panel of doctors, including Dr. James Dunn, Chief of the Division of Pediatric Surgery at Stanford University. They had a choice—they could proceed with a surgery in which doctors would attempt to remove the dead and dying parts of Diego’s intestine—or they could just spend whatever time remained with him. But if they went forward, Diego’s life would be very different from what they had imagined. The surgery would likely leave him with nearly ultra short bowel syndrome (SBS), meaning he would not have enough small intestine to absorb adequate nutrition. Instead of eating normally, he would have to rely on intravenous feeding. Also called total parenteral nutrition (TPN), the practice comes with its own slew of risks including central line infection and liver failure.
“My biggest question was ‘what would his quality of life be?’” recalled David. “Will he be suffering? I needed some answers so I could try to make the right decision for my family.”
“We had less than an hour to decide,” said Italia.
Speaking with clarity and directness, Dr. Dunn’s words cut through the fog of their swirling thoughts and fears. “He recommended going in to take a look, and said the surgeon would remove whatever looked bad, and leave anything that looked okay,” recalled David. “He was incredibly frank and to the point. It was exactly what we needed.”
The DeLeons decided to give the surgery – and Diego – a chance.
Diego made it through the first surgery, but just days later, had to go back in for a second procedure. “The doctors had tried to preserve some intestinal tissue, but it was iffy. It was grey and dying and so they had to go back in and take more out,” said Italia. “I felt like my heart was just stuck. I couldn’t think, couldn’t breathe, and the bad news just kept stacking up.”
Only after the second procedure did the DeLeons get a small ray of hope – on Dr. Dunn’s counsel, the surgeon had been able to preserve a tiny bit of Diego’s ileum, the final section of the small intestine. “They thought that would make it possible for him to digest some food through his gastrointestinal tract in the future,” said Italia.
Coming home
Six months after he was born, Diego finally came home. He had a gastrostomy tube (G-tube), which was inserted through his belly to provide nutrition directly to the stomach for daytime feedings. At night, he received TPN through a catheter in his chest. Over time, his parents gradually introduced small oral feedings as well.
Italia and David became experts in short bowel care. Italia’s sister, a nurse, provided full-time nursing five days a week. Italia’s mom, who lived with them, helped out too. Together, they managed Diego’s day and night feedings; counting calories, flushing lines, troubleshooting problems that often disrupted their sleep, and monitoring his bowels. They watched his proximity to others, because even a cold could land him in the hospital with a central line infection. And they worried.
“I just thought, will this kid ever be able to eat normally?” recalled David. “I love food – we all love food. And thinking that he wouldn’t was just the saddest thing.”
A Long Road
25 years earlier, as a pediatric surgery fellow, Dunn had been thinking about the same thing. During medical school, he observed several scenarios in which physicians induced bone or tissue growth through distraction: the gradual application of controlled force. He thought it might be possible to use a similar approach to stimulate intestinal growth in kids with SBS.
Over the next 12 years, he did research and published papers showing that the process, called distraction enterogenesis, not only lengthened the intestine, but also that the newly-created tissue looked and functioned like normal, healthy tissue. Although he patented his approach, it languished until Dunn met Tom Krummel, MD, then co-director of Stanford Biodesign and Fogarty Innovation board chair, and Andre Bessette, an experienced medtech entrepreneur. Together they formed Eclipse Regenesis. CEO Bessette raised seed funding and Eclipse became a company-in-development at Fogarty Innovation. “It turns out that patenting an idea is just the beginning of a long journey to bring an innovation to the patient’s bedside,” Dunn said.
Last year, Dunn finally got to see his concept become a clinical reality when Eclipse successfully treated its first adult SBS patient as part of an FDA study designed to prove device safety. In the procedure, the Eclipse XL1 System, a small spring-like device, is placed inside of the small intestine in a compressed state. As it gradually lengthens, it exerts a controlled stretch force to stimulate the growth of new tissue. After the XL1 has fully expanded, it is released, travels through the rest of the digestive tract and passes out of the patient.
Compassionate use
While still working to complete the initial studies on adult patients as required by FDA, the Eclipse team also applied for the compassionate use pathway. “The device does not yet have FDA approval,” said Dunn. “But if you have a patient that has no alternatives, they will allow you to use the device on this basis. In this way, we got permission to use this procedure on a pediatric patient who we believed would benefit.” The patient was Diego.
“Diego had been struggling to rehabilitate intestinal function and come off TPN,” said Dr. Shweta Namjoshi, Medical Director, Intestinal Rehabilitation and a Clinical Associate Professor at Stanford Medicine. “Many children in our program are able to stop TPN within three years of their initial intestinal resection, but Diego was not progressing as we had hoped or expected with traditional methods and medications. I felt comfortable trying an innovative approach because of the decades of rigorous science Dr. Dunn put into this device. It made me feel that distraction enterogenesis was a reasonable option to try to advance intestinal rehabilitation for Diego.”
Let’s do it
When the possibility of using the Eclipse system to achieve intestinal lengthening was discussed, both Italia and David agreed. “It kind of brought me back to that initial call we had to make—do you want to step into the unknown, or just treasure what you have for as long as you have it,” said Italia. “For me, whenever there’s an opportunity to improve his quality of life and his chances to have a more normal life, it’s a no-brainer.”
“We have a lot of trust and faith in Dr. Dunn,” said David. “He told us about the procedure in his usual straightforward way—this is what we have, this is the study, these are the results we’ve seen, etc. His confidence in this treatment really erased any questions I might have had.”
“Plus, as Dr. Namjoshi pointed out, there’s not a lot of other options,” Italia continued. “Any procedure you do is going to involve risk. You have to weigh the pros and cons. But for us, I feel like Diego has shown us since birth that he has the fighting spirit—that he wants to be here—and we need to match that.”
Getting a victory
With Dunn heading up the surgery, Diego had the Eclipse procedure in June 2024. Over the next weeks, his x-rays showed the device working as intended. Diego started to have fewer, more normally-formed bowel movements and began to gain weight.
“Until then, it seemed like every time we went to the hospital, it was because something bad was happening,” said David. “Finally, the spring procedure gave us some good news.” As Diego started eating more orally, the DeLeons were able to first cut back and then eliminate the nightly TPN feedings.
“It felt so good to finally get a victory,” David said. “There are other things going on with Diego other than the intestine, but through all that darkness, this was a little bit of light. This procedure has been a positive thing for him and we’re looking forward to continuing the therapeutic process.”
“The spring was able to lengthen the intestine by a couple of centimeters,” reported Dunn. “And while that isn’t much, it is remarkable that Diego came off the parenteral nutrition support altogether and is able to eat. So rather than just adding more intestine, we seem to have stimulated the rest of the GI tract in some way that made the rest of the intestine work better,” he said. “Of course this needs to be studied. But if it is true, it could completely change the paradigm of how we treat these patients.”
Hope for the future
Today, Diego is an active, nearly three-year old, running around, playing, and best of all, eating. “He wants to eat everything,” said Italia. “Even when he has his own plate of food, he wants to try everything that we have.”
“I’m just hoping this procedure is something that’s going to be commercially available in his lifetime because we have seen such a big change,” said David. “ And if we can continue to repeat this process, he may get even closer to normal absorption and a normal lifestyle—maybe even a future without a G-tube.”
According to Bessette, the clinical goal is to be able to use multiple Eclipse devices sequentially until sufficient lengthening is achieved. In addition to continuing the FDA feasibility study, the Eclipse team is also working on a minimally invasive approach for deployment of the device which will allow for even more patients with SBS to be treated.
David continued, “I’m just glad that there are doctors and entrepreneurs interested in doing this for my son and hopefully others like him moving forward. It’s given us hope, and I know it could do the same for other kids. It’s exciting and beautiful and we are so appreciative.”
The Eclipse XL1 System is an investigational device that has not been approved by the FDA. Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK127658. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.