Who is sponsoring NCT03793816?

NCT03793816 is sponsored by Medical University of Vienna.

What drugs are being tested in NCT03793816?

Interventions in NCT03793816: BiZactTM Open Sealer/Divider.

What condition does NCT03793816 study?

NCT03793816 studies Tonsillitis Chronic, Tonsillectomy, Hemorrhage, Postoperative Pain, Postoperative Hemorrhage, Surgery--Complications, Handling, Otorhinolaryngologic Diseases.

Is NCT03793816 still recruiting?

NCT03793816 is currently completed. Last updated 5 January 2021.

Last reviewed 2021-01-05 · How we verify

NCT03793816

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

Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial

Completed NA Last updated 5 January 2021

What this trial tests

NA trial testing BiZactTM Open Sealer/Divider in Tonsillitis Chronic in 48 participants. Completed in 21 December 2020.

Timeline

1 September 2019

Primary endpoint
23 October 2020

21 December 2020

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	48
Start date	1 September 2019
Primary completion	23 October 2020
Estimated completion	21 December 2020
Sites	1 location across Austria

Drugs / interventions tested

BiZactTM Open Sealer/Divider

Conditions studied

Tonsillitis Chronic — all drugs for Tonsillitis Chronic →
Tonsillectomy — all drugs for Tonsillectomy →
Hemorrhage — all drugs for Hemorrhage →
Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Medical University of Vienna

Who can join

Adults 14 to 85, any sex, with Tonsillitis Chronic or Tonsillectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous. Constant evaluation of surgical techniques is paramount to improve safety and cost-effectiveness. Frequently tonsillectomies are performed in cold steel technique. Aim of this study will be the evaluation of handling, surgical time, postoperative pain and postoperative hemorrhage rates using the BiZactTM-Device in comparison to traditional techniques on the contralateral side. In one patient, two different techniques will be used. The primary objective will be the surgical time. Regardless of surgeon handedness, surgeons will randomly be assigned to either start with the left or right tonsil, and randomly either to start with the BiZact™ Device or with "cold steel" methods. Additionally, time to stop bleeding, intraoperative blood loss, tonsil mobility, device handling, as well as wound healing will be assessed.

Publications & conference data

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

A novel electrosurgical divider: performance in a self-controlled tonsillectomy study.
Besser G, Grasl S, Meyer EL, Schnoell J, et al · · 2022 · cited 6× · PMID 34338876 · DOI 10.1007/s00405-021-07008-9

Verify or expand the search:

Other recruiting trials for Tonsillitis Chronic

Currently open trials in the same condition.

NCT07035314 — The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsi · NA · recruiting
NCT03654742 — Intracapsular Tonsillectomy in Adults · NA · active not recruiting

Other Medical University of Vienna trials

Trials by the same sponsor.

NCT07473401 — Retinal Oxygen Metabolism in Children With Myopia · not yet recruiting
NCT07511400 — The Role of NaV1.8 in Human Pain Models · EARLY_PHASE1 · not yet recruiting
NCT07516990 — Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoper · NA · recruiting
NCT07496437 — Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? · NA · not yet recruiting
NCT07290712 — Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region · 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 NCT03793816 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Medical University of Vienna
Last refreshed: 5 January 2021

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/NCT03793816.

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