NCT05174910 (ORSY) is a NA clinical trial of Obsidian ASG in Anastomotic Leak Rectum, sponsored by Vivostat.

Who is sponsoring NCT05174910?

NCT05174910 is sponsored by Vivostat.

What drugs are being tested in NCT05174910?

Interventions in NCT05174910: Obsidian ASG.

What condition does NCT05174910 study?

NCT05174910 studies Anastomotic Leak Rectum.

Is NCT05174910 still recruiting?

NCT05174910 is currently active, enrolled. Last updated 25 July 2024.

Last reviewed 2024-07-25 · How we verify

NCT05174910: ORSY

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

Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery

Active, enrolled NA Last updated 25 July 2024

What this trial tests

NA trial testing Obsidian ASG in Anastomotic Leak Rectum in 250 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 December 2021

Primary endpoint
31 October 2024

31 December 2024

Quick facts

Lead sponsor	Vivostat
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	250
Start date	23 December 2021
Primary completion	31 October 2024
Estimated completion	31 December 2024
Sites	13 locations across Italy, Serbia, Austria, Germany, Spain

Drugs / interventions tested

Obsidian ASG

Conditions studied

Anastomotic Leak Rectum — all drugs for Anastomotic Leak Rectum →

Sponsor

Vivostat

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

Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs. This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x125 patients The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique. The secondary objectives of the study are to investigate on an exploratory basis: * The frequency of anastomotic insufficiency (ISREC Criteria) severity * Staple line bleeding requiring surgical intervention * The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone. are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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 NCT05174910 (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 Vivostat
Last refreshed: 25 July 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/NCT05174910.

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