Patients sometimes drive hundreds of miles to see their GI physicians for problems that never seem to resolve. Constipation is one of those ailments that can affect quality of life.
The advice is, “Try this diet or laxative. Get a colonoscopy. Often, that’s not getting at the root problem,” said Eric Dinesh Shah, MD, MBA, a gastroenterologist at the University of Michigan, Ann Arbor.
Such methods aren’t equipped to test the pelvic floor, said Dr. Shah, who worked with clinical experts to develop a simple point-of-care device called RED (rectal expulsion device) that makes it easier to diagnose and predict treatment options for constipation.
The device uses a foam-filled balloon to evaluate pelvic floor problems related to constipation, after a digital rectal exam during an office visit. Because the procedure can be performed during a patient’s initial office visit, it can eliminate the need for referrals to far-away specialists for many patients.
In 2019, Dr. Shah received the AGA-Shire Research Scholar Award in Functional GI and Motility Disorders from the AGA Research Foundation for developing RED, and the device was recently cleared by the Food and Drug Administration.
GI doctors don’t always have the answers, he acknowledged in an interview, but this creates the opportunity for new advancements such as RED. utilizing local and regional workshops as well as national conferences to meet like-minded people at similar career stages, and to look for funding opportunities to explore those ideas.
What is the most challenging case you’ve encountered?
Dr. Shah: The most challenging cases to me have been the ones where I wish we could have helped people years ago. It’s not that anyone did anything wrong or was poorly intentioned. It’s quite the opposite: There sometimes is no real avenue to offer testing locally with current technology, even though the local clinical teams completely understand what should be done in a perfect world. That creates challenges where patients go hours out of their way to see specialists, just to find an answer that might have been 1 mile down the road all along.
What has been your solution to help these patients?
Dr. Shah: My work has been about helping patients who drive a hundred miles or routinely go hours out of their way for their care. Usually that’s a sign that things just aren’t working locally. Patients have lost trust in their ability to get care with the teams they have. Or the teams themselves just need help. I think a major part of the job is to reinforce the bond between the patient and their local team by giving them the tools and expertise so that the patients can get that care locally.
There’s been this trend toward this ‘hub and spoke’ model in care where all the patients are filtering into these large hospital-owned mega practices. I wonder about the sustainability of that model because it takes away the ability of patients to see doctors who are invested in their local community. What we need to be doing is trying to flip that.
I’d love to discuss the RED device and how was this device conceived?
Dr. Shah: I partnered with experts, including William Chey, MD, AGAF, at the University of Michigan, who dedicate their entire careers toward creating robust science in large academic medical centers. In understanding the best ways to care for patients today, I could focus my own career on how to translate that level of care for the patients of tomorrow. I would encourage GI trainees to find senior and peer mentors who share perspective on this approach as an anchor to shared success.
For the RED device, the problem in constipation is that patients see their gastroenterologist over and over and over. It’s ‘try this diet, try this laxative, try this drug, try this other treatment,’ and we’re not getting at the root problem. Patients might go through a series of colonoscopies to reassure them but also to reassure their doctor that they’re not missing something. What we haven’t had is a way to test and evaluate the pelvic floor locally because those technologies are high tech and live in these big academic medical centers.
What are plans for its distribution and use in the consumer space?
Dr. Shah: The device is now available in the United States (https://www.red4constipation.com).
As an AGA Research Scholar Award winner, how might AGA play a role in supporting GI doctors?
Dr. Shah: The AGA Research Scholar Award enabled me to learn how RED predicted outcomes for patients seeing general gastroenterologists who then see pelvic floor physical therapy in the community to treat constipation. The availability of pelvic floor physical therapy and the field at large, has exploded in recent years across the country (https://www.pelvicrehab.com), making it easier for patients to get the local care they need.
In looking at what this award did for my own career and those of others in my cohort, I think the AGA Research Scholar Award mechanism serves as an example of what other GI trainees can do across the many areas of GI that are ripe for transformation.
What other AGA workshops are useful to GI doctors?
Dr. Shah: The AGA Tech Summit and Innovation Fellows programs give access to a positive learning environment to network with people across career stages who are seeking to advance the field in this way. These programs are particularly successful because they focus on helping GI trainees find peer success and professional satisfaction in the shared journey, rather than focusing on the accolades. I would strongly encourage GI trainees who have an interest but don’t know where to start to apply for these programs.
What do you think is the biggest misconception about your specialty?
Dr. Shah: That gastroenterologists have all the answers with current technology. There’s a lot we still don’t know. What gives me reassurance is the momentum around new ways of thinking that GI trainees and early-stage gastroenterologists continually bring forward to improve how we care for patients.
Lightning Round
Do you prefer coffee or tea?
Coffee
Are you an early bird or night owl?
Early bird
What’s your go-to comfort food?
Tex Mex
If you could travel anywhere, where would you go?
Antarctica
What’s your favorite TV show?
Below Deck
What’s one hobby you’d like to pick up?
Painting
What’s your favorite way to spend a weekend?
A lazy weekend
If you could have dinner with any historical figure, who would it be?
Winston Churchill
What’s your go-to karaoke song?
Our endoscopy nurses give no choice other than Taylor Swift, Green Day, and the Backstreet Boys
Summary content
7 Key Takeaways
-
1
Developed a paper-based colorimetric sensor array for chemical threat detection.
-
2
Can detect 12 chemical agents, including industrial toxins.
-
3
Production cost is under 20 cents per chip.
-
4
Utilizes dye-loaded silica particles on self-adhesive paper.
-
5
Provides rapid, simultaneous identification through image analysis.
-
6
Inspired by the mammalian olfactory system for pattern recognition.
-
7
Future developments include a machine learning-enabled reader device.
The guidelines emphasize four-hour gastric emptying studies over two-hour testing. How do you see this affecting diagnostic workflows in practice?
Dr. Staller: Moving to a four-hour solid-meal scintigraphy will actually simplify decision-making. The two-hour reads miss a meaningful proportion of delayed emptying; standardizing on four hours reduces false negatives and the “maybe gastroparesis” purgatory that leads to repeat testing. Practically, it means closer coordination with nuclear medicine (longer slots, consistent standardized meal), updating order sets to default to a four-hour protocol, and educating front-line teams so patients arrive appropriately prepped. The payoff is fewer equivocal studies and more confident treatment plans.
Metoclopramide and erythromycin are the only agents conditionally recommended for initial therapy. How does this align with what is being currently prescribed?
Dr. Staller: This largely mirrors real-world practice. Metoclopramide remains the only FDA-approved prokinetic for gastroparesis, and short “pulsed” erythromycin courses are familiar to many of us—recognizing tachyphylaxis limits durability. Our recommendation is “conditional” because the underlying evidence is modest and patient responses are heterogeneous, but it formalizes what many clinicians already do: start with metoclopramide (lowest effective dose, limited duration, counsel on neurologic adverse effects) and reserve erythromycin for targeted use (exacerbations, bridging).
Several agents, including domperidone and prucalopride, received recommendations against first-line use. How will that influence discussions with patients who ask about these therapies?
Dr. Staller: Two points I share with patients: evidence and access/safety. For domperidone, the data quality is mixed, and US access is through an FDA IND mechanism; you’re committing patients to EKG monitoring and a non-trivial administrative lift. For prucalopride, the gastroparesis-specific evidence isn’t strong enough yet to justify first-line use. So, our stance is not “never,” it’s just “not first.” If someone fails or cannot tolerate initial therapy, we can revisit these options through shared decision-making, setting expectations about benefit, monitoring, and off-label use. The guideline language helps clinicians have a transparent, evidence-based conversation at the first visit.
The guidelines suggest reserving procedures like G-POEM and gastric electrical stimulation for refractory cases. In your practice, how do you decide when a patient is “refractory” to medical therapy?
Dr. Staller: I define “refractory” with three anchors.
1. Adequate trials of foundational care: dietary optimization and glycemic control; an antiemetic; and at least one prokinetic at appropriate dose/duration (with intolerance documented if stopped early).
2. Persistent, function-limiting symptoms: ongoing nausea/vomiting, weight loss, dehydration, ER visits/hospitalizations, or malnutrition despite the above—ideally tracked with a validated instrument (e.g., GCSI) plus nutritional metrics.
3. Objective correlation: delayed emptying on a standardized 4-hour solid-meal study that aligns with the clinical picture (and medications that slow emptying addressed).
At that point, referral to a center with procedural expertise for G-POEM or consideration of gastric electrical stimulation becomes appropriate, with multidisciplinary evaluation (GI, nutrition, psychology, and, when needed, surgery).
What role do you see dietary modification and glycemic control playing alongside pharmacologic therapy in light of these recommendations?
Dr. Staller: They’re the bedrock. A small-particle, lower-fat, calorie-dense diet—often leaning on nutrient-rich liquids—can meaningfully reduce symptom burden. Partnering with dietitians early pays dividends. For diabetes, tighter glycemic control can improve gastric emptying and symptoms; I explicitly review medications that can slow emptying (e.g., opioids; consider timing/necessity of GLP-1 receptor agonists) and encourage continuous glucose monitor-informed adjustments. Pharmacotherapy sits on top of those pillars; without them, medications will likely underperform.
The guideline notes “considerable unmet need” in gastroparesis treatment. Where do you think future therapies or research are most urgently needed?
Dr. Staller: I see three major areas.
1. Truly durable prokinetics: agents that improve emptying and symptoms over months, with better safety than legacy options (e.g., next-gen motilin/ghrelin agonists, better-studied 5-HT4 strategies).
2. Endotyping and biomarkers: we need to stop treating all gastroparesis as one disease. Clinical, physiologic, and microbiome/omic signatures that predict who benefits from which therapy (drug vs G-POEM vs GES) would transform care.
3. Patient-centered trials: larger, longer RCTs that prioritize validated symptom and quality-of-life outcomes, include nutritional endpoints, and reflect real-world medication confounders.
Our guideline intentionally highlights these gaps to hopefully catalyze better trials and smarter referral pathways.
Dr. Staller is with the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston.