NCT05561127 (PATENT-B) is a Phase 3 clinical trial of GIE Medical ProTractX3 TTS DCB in Bowel; Stricture, sponsored by GIE Medical.

Who is sponsoring NCT05561127?

NCT05561127 is sponsored by GIE Medical.

What drugs are being tested in NCT05561127?

Interventions in NCT05561127: GIE Medical ProTractX3 TTS DCB, Control.

What condition does NCT05561127 study?

NCT05561127 studies Bowel; Stricture.

Is NCT05561127 still recruiting?

NCT05561127 is currently recruiting now. Last updated 25 June 2025.

Last reviewed 2025-06-25 · How we verify

NCT05561127: PATENT-B

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel

Recruiting now Phase 3 Last updated 25 June 2025

What this trial tests

Phase 3 trial testing GIE Medical ProTractX3 TTS DCB in Bowel; Stricture in 171 participants. Currently enrolling.

Timeline

1 November 2023

Primary endpoint
1 December 2027

1 June 2032

Quick facts

Lead sponsor	GIE Medical
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	171
Start date	1 November 2023
Primary completion	1 December 2027
Estimated completion	1 June 2032
Sites	33 locations across United States

Drugs / interventions tested

GIE Medical ProTractX3 TTS DCB
Control

Conditions studied

Bowel; Stricture — all drugs for Bowel; Stricture →

Sponsor

GIE Medical

Who can join

22 and older, any sex, with Bowel; Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures.
Shen B, Adorno-Garayo CR. · · 2024 · cited 3× · PMID 41648897 · DOI 10.1016/j.igie.2023.12.002

Verify or expand the search:

Other GIE Medical trials

Trials by the same sponsor.

NCT03997994 — DIGEST I Drug Coated Balloon for Biliary Stricture · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05561127 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
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: 25 June 2025

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/NCT05561127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing