Trials / Completed
CompletedNCT07518693
Clinical Observation of Hysteroscopy-Assisted Placement of Handmade Frameless GyneFix-LNG-IUS (Retrospective Cohort)
Handmade Frameless Levonorgestrel-Releasing Intrauterine System for Chinese Patients: A Retrospective Self-Controlled Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Yu Wang · Other Government
- Sex
- Female
- Age
- 25 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This is a retrospective self-controlled observational study. We evaluated the safety and efficacy of a handmade frameless levonorgestrel-releasing intrauterine system (GyneFix-LNG-IUS) in patients at high risk of IUD expulsion. The device was constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed. All data were collected from routine clinical records. The primary outcome was device expulsion or migration during follow-up.
Conditions
- Intrauterine Device Expulsion
- Adenomyosis, Endometriosis
- Menorrhagia, Dysmenorrhea
- Abnormal Uterine Bleeding
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Handmade Frameless GyneFix-LNG-IUS | A handmade frameless levonorgestrel-releasing intrauterine system, constructed by combining the GyneFix IUD anchor system and a conventional LNG-IUS with the T-shaped arms removed, for placement in high-risk patients to reduce IUD expulsion. |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2024-10-31
- Completion
- 2024-10-31
- First posted
- 2026-04-08
- Last updated
- 2026-04-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07518693. Inclusion in this directory is not an endorsement.