An interventional study of The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System in Hypoglycemia, Gastric Outlet Obstruction and Steatohepatitis, sponsored by University Hospital, Ghent. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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Among 10 studies in Hypoglycemia with a site in Belgium — 3 open to participants now, 4 under way, none of them phase 3. Hypoglycemia · Belgium.
Among the 10 studies in Hypoglycemia with a site in Belgium, this one is the only one that started in 2023, is one of 5 with no phase, and was the 7th registered.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
Browse Hypoglycemia studies →3 of the 10 studies in Hypoglycemia with a site in Belgium are open now. Recruiting first, the newest first:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Sites in Belgium
Ages 2–30 · Healthy volunteers
Prof. Valérie Mc Lin · Sites in Belgium, United States, Australia and 13 more countries
Ages 1 days+
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 59 Hypoglycemia studies recruiting now, 23 (39%) set no upper age limit and 31 (53%) stop at 75 or younger; 18 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3
First in 2008; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Median enrollment 71 across the 8 interventional studies, 270 across the 2 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
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3 of 10 have an industry lead sponsor. The 10 most frequent:
University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
University Hospital, Ghent has 1 study filed under Hypoglycemia — fewer than ten, so there is no comparison to draw.
1 of the studies in Hypoglycemia with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05640947University Hospital, GhentEndoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass | 2027-10 |
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Among the 10 studies in Hypoglycemia with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of significant portal hypertension as demonstrated by 2.1) the presence of esophageal and/or gastric varices AND/OR 2.2) a hepatic venous pressure gradient (if measured) equal to or more than 10mm Hg AND/OR 2.3) the combination of
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
EUS-guided gastro-gastrostomy using the Hot Axios device: Using a therapeutic endoscopic ultrasound endoscope with a working channel of 3.7mm and under fluoroscopic control, the excluded stomach will be identified and punctured with a 19G needle. Contrast injection will confirm the good position of the needle in the excluded stomach. If needed, the excluded stomach will be filled with blue-stained aqua (5% indigocarmine) until a sufficient distension is obtained for placement of the lumen-apposing metal stent. A lumen-apposing metal stent with a diameter of 20mm will be used according to the manufacterers' instructions to create a gastrogastrostomy. Position will be checked with fluoroscopy.
Also known as: LAMS
clinical succes rate
1. for patients needing parenteral support: the number of parenteral supplements over a 6-month timeframe. 2. for patients with symptomatic hypoglycemia: resolution of hypoglycemia- associated complaints + negative hypoglycemia-provocative testing (oral glucose tolerance test and/or mixed meal test) at 6 months post-intervention. 3. for patients with gastric outlet obstruction: resolution of gastric outlet obstruction- associated symptoms at 6 months post-intervention. 4. for patients with steatohepatitis and signs of liver failure: improvement of liver function (significant drop in bilirubin/INR; increase in serum albumin) at 6 months post-intervention.
Time frame: 6 months
Technical success rate
Correct placement of the lumen-apposing metal stent in the desired position, scored yes/no
Time frame: 12 months
Duration of the procedure
time interval from scope introduction to successful deployment of the lumen-apposing metal stent.
Time frame: 12 months
Complication rate
These include procedure-related complications such as bleeding, perforation, stent migration, peritonitis, reflux disease … Complications will be divided into early (within 24h) and late (after 24h but within 30 days) complications. The severity of each complication will be scored as followed: 1. mild: requiring admission or prolongation of planned admission \<3 days; 2. moderate: requiring prolongation of planned admission to 3-10 days; 3. severe: requiring prolongation of planned admission to more than 10 days or requiring surgery; 4. fatal: leading to death
Time frame: 12 months
Reintervention rate
endoscopic and/or surgical, reason should be clearly mentioned: due to loss of stent patency, stent migration, side-effects,…
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Oct 2027, 57 months after the start.
Of 169 non-industry interventional studies with no phase under Hypoglycemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 57 months is above that.
Counting every sponsor, half of 175 studies reached it within 17 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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