A prospective, randomized, controlled trial to evaluate the efficacy, tolerability, and feasibility of a single-use disposable hysteroscopic operating system in an outpatient office setting
Outpatient diagnostic or operative office hysteroscopy due to suspected intra-uterine pathology
Method of randomization: Patients were randomly assigned (1:1 ratio) to either the experimental group (RedPine Single-Use Disposable System) or the control group (Standard Reusable System). The randomization sequence was generated prior to study initiation using a computer-generated random number software program. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only immediately prior to the hysteroscopic procedure. Study Group (single-use disposable System): Patients undergo outpatient diagnostic or operative office hysteroscopy using the single-use disposable hysteroscopic operating system. The system is utilized for visual evaluation of the uterine cavity and execution of targeted minor operative procedures (e.g., endometrial polyp resection, septum incision, targeted biopsies). Reference Group (Standard Reusable System): Patients undergo outpatient diagnostic or operative office hysteroscopy using the standard reusable hysteroscopic system currently in routine clinical use at the department, following identical clinical protocols for distension medium, access, and operative techniques. Follow-up: Patient pain scores and immediate post-procedural complications are assessed immediately after the procedure and prior to discharge.
1. Female patients scheduled for outpatient diagnostic or operative office hysteroscopy due to suspected intra-uterine pathology (e.g., endometrial polyps, uterine septum, abnormal uterine bleeding [AUB], or thickened endometrium) 2. Age between 18 and 80 years 3. Provided written informed consent prior to study enrollment
1. Severe pelvic organ prolapse 2. Active pelvic inflammatory disease (PID) or lower genital tract infection 3. Confirmed or suspected ongoing pregnancy 4. Inability to understand the study protocol or refusal to sign the written informed consent