An observational study in Gastrointestinal Neoplasia, Hirschsprung's Disease and Esophageal Obstruction, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Colorado, Denver · Observational
Among 11 studies in Hirschsprung Disease with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Hirschsprung Disease · United States.
Among the 11 studies in Hirschsprung Disease with a site in United States, this one is the only one that started in 2018, is one of 7 observational ones, and was the 8th registered.
63 studies on the registry are indexed under Hirschsprung Disease; 24 are open to participants now.
Browse Hirschsprung Disease studies →4 of the 11 studies in Hirschsprung Disease with a site in United States are open now. Recruiting first, the newest first:
Seattle Children's Hospital · Sites in United States
Ages 0 days–55 yrs
Ilya Khaytin · Sites in United States
Sanford Health · Sites in United States
NYU Langone Health · Sites in United States
Ages 1 wk–100 yrs · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Hirschsprung Disease studies recruiting now, 7 (50%) set no upper age limit and 6 (43%) stop at 75 or younger; 14 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes.
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11 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 2
First in 2001; this study’s year is marked. 1 started in 2018.
This study's enrollment of 250 is below the median of 300 across 31 observational studies indexed under Hirschsprung Disease.
Median enrollment 56 across the 4 interventional studies, 1,000 across the 7 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
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None of the 11 has an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Hirschsprung Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Hirschsprung Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06072976Seattle Children's HospitalThe Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies | 2027-06-09 |
Among the 11 studies in Hirschsprung Disease with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.
The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.
A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.
A prospective database/registry of patients undergoing submucosal endoscopic procedures will be formed. Women and minorities will be included as they are frequently found to have indications for which submucosal endoscopic procedures may be indicated.
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:
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.
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.
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.
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.
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.
Technical and clinical success in performing submucosal endoscopy
Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.
Time frame: baseline to one year
Adverse Events
as defined by published ASGE criteria
Time frame: baseline to one year
Procedure time
Procedure time
Time frame: During procedure
Submucosal endoscopy technique and device used
Submucosal endoscopy technique and device used
Time frame: During procedure
Started Jun 2018 (actual). Primary completion is estimated for Jun 2025, 84 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →