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Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

Study acronym: BARHYSTER
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 2026 to Jan 2027 Completion date: Jan 2027 to Aug 2027v8 Show 1 more changeShow less
    • Completion date: Jan 2027 to Aug 2027
  2. Primary completion date: Jul 2025 to Jul 2026 Completion date: Jan 2026 to Jan 2027v7 Show 1 more changeShow less
    • Completion date: Jan 2026 to Jan 2027
  3. Re-verified, no change to tracked fieldsv6
  4. Site details revised at 1 of 2 sitesv5
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2024 to Mar 19, 2024 · Site details revised at 2 of 2 sites · Study title shortened, about 4 wordsv4 Show 3 more changesShow less
    • Start date changed from estimate of Mar 2024 to Mar 19, 2024
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Nov 2023 to Mar 2024 Primary completion date: Mar 2025 to Jul 2025 · Completion date: Sep 2025 to Jan 2026v3 Show 2 more changesShow less
    • Primary completion date: Mar 2025 to Jul 2025
    • Completion date: Sep 2025 to Jan 2026
  2. Start date: Sep 2023 to Nov 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aesculap AG
32 trials monitored
See 6 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
Cervical Cancer
859 trials monitored
See 43 trials at risk
Endometrial Cancer
633 trials monitored
See 40 trials at risk
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.
Trial Details
NCT Number NCT06024109
Lead Sponsor Aesculap AG
Collaborators: B.Braun Surgical SA
Conditions Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer, Ovarian Cancer, Fallopian Tube Cancer, Cervical Cancer, Endometrial Cancer
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov