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NCT06068127: GESOM
G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through
trial in Gastroparesis in 30 participants. Status unknown.
22 March 2024
Quick facts
| Lead sponsor | Institute for Clinical and Experimental Medicine |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 12 October 2023 |
| Primary completion | 22 March 2024 |
| Estimated completion | 22 March 2024 |
| Sites | 2 locations across France, Czechia |
Conditions studied
- Gastroparesis — all drugs for Gastroparesis →
- Esophageal Cancer — all drugs for Esophageal Cancer →
Sponsor
Institute for Clinical and Experimental Medicine
Who can join
18 and older, any sex, with Gastroparesis or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM. The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure. For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06068127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
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Currently open trials in the same condition.
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Other Institute for Clinical and Experimental Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06068127 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute for Clinical and Experimental Medicine
- Last refreshed: 15 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06068127.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing