NCT04386148 is a clinical trial of Obsidian ASG® in Anastomotic Leak Rectum, sponsored by Kepler University Hospital.

Who is sponsoring NCT04386148?

NCT04386148 is sponsored by Kepler University Hospital.

What drugs are being tested in NCT04386148?

Interventions in NCT04386148: Obsidian ASG®.

What condition does NCT04386148 study?

NCT04386148 studies Anastomotic Leak Rectum.

Is NCT04386148 still recruiting?

NCT04386148 is currently completed. Last updated 5 October 2023.

Last reviewed 2023-10-05 · How we verify

NCT04386148

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

Impact of Obsidian ® ASG on Anastomotic Healing

Completed Last updated 5 October 2023

What this trial tests

trial testing Obsidian ASG® in Anastomotic Leak Rectum in 270 participants. Completed in 31 December 2021.

Timeline

1 June 2018

Primary endpoint
31 March 2021

31 December 2021

Quick facts

Lead sponsor	Kepler University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	270
Start date	1 June 2018
Primary completion	31 March 2021
Estimated completion	31 December 2021
Sites	1 location across Austria

Drugs / interventions tested

Obsidian ASG®

Conditions studied

Anastomotic Leak Rectum — all drugs for Anastomotic Leak Rectum →

Sponsor

Kepler University Hospital

Who can join

18 and older, any sex, with Anastomotic Leak Rectum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Anastomotic Leak Rectum

Currently open trials in the same condition.

NCT05174910 — Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastom · NA · active not recruiting

Other Kepler University Hospital trials

Trials by the same sponsor.

NCT06030986 — Prediction of Outcome in Out-of-Hospital Cardiac Arrest · not yet recruiting
NCT06574906 — Machine Learning Prediction of Parameters of Early Warning Scores in General Wards · active not recruiting
NCT07506005 — Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line · recruiting
NCT06259812 — Machine Learning Prediction of Parameters of Early Warning Scores in Intensive Care Units · active not recruiting
NCT05753995 — Immuno-Positron Emission Tomography (PET)-Glioma Study, a Proof-of-principle Imaging Study · NA · active not recruiting

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 NCT04386148 (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 Kepler University Hospital
Last refreshed: 5 October 2023

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/NCT04386148.

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