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NCT03997994: DIGEST
DIGEST I Drug Coated Balloon for Biliary Stricture
NA trial testing GIE Drug Coated Balloon in Biliary Stricture in 8 participants. Status unknown.
21 March 2024
Quick facts
| Lead sponsor | GIE Medical |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 12 May 2019 |
| Primary completion | 21 March 2024 |
| Estimated completion | 21 March 2025 |
| Sites | 1 location across Paraguay |
Drugs / interventions tested
- GIE Drug Coated Balloon
Conditions studied
- Biliary Stricture — all drugs for Biliary Stricture →
- Biliary Anastomotic Stenosis — all drugs for Biliary Anastomotic Stenosis →
- Biliary Obstruction — all drugs for Biliary Obstruction →
- Biliary Disease — all drugs for Biliary Disease →
Sponsor
GIE Medical
Who can join
Adults 18 to 80, any sex, with Biliary Stricture or Biliary Anastomotic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03997994
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT05210322 — Percutaneous Cholangiopancreatoscopy Registry · active not recruiting
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Other GIE Medical trials
Trials by the same sponsor.
- NCT05561127 — Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel · Phase 3 · recruiting
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 NCT03997994 (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 GIE Medical
- Last refreshed: 17 August 2022
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/NCT03997994.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing