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Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
NCT05570916 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
Conditions Studied
Interventions
- DEVICE Zip-stitch(R)
- DEVICE Reference suture
Study Locations (5)
Illinois
- Northwestern University — Chicago
North Carolina
- Unified Women's Clinical Research — Winston-Salem
Pennsylvania
- Lankenau Hospital — Wynnewood
Virginia
- Tidewater Clinical Research — Virginia Beach
West Virginia
- Mon Health Medical Center — Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2025-05-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05570916
The ClinicalTrials.gov registry entry for NCT05570916 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZSX Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Laparoscopic Hysterectomy appearing as the primary indexed condition, and to 2 interventions — of which Zip-stitch(R) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05570916 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, North Carolina, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05570916 about?
NCT05570916 is a clinical study titled "Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy". The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two...
What is the current status of trial NCT05570916?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 59 participants. The study started on 2023-08-17. Estimated completion is 2025-05-10.
What conditions does trial NCT05570916 study?
This clinical trial studies the following conditions: Laparoscopic Hysterectomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05570916?
The interventions under investigation include: Zip-stitch(R) (DEVICE), Reference suture (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05570916?
This trial is sponsored by ZSX Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05570916 being conducted?
This trial has 5 study locations across Illinois, North Carolina, Pennsylvania, Virginia, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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