Evaluating a single-use disposable hysteroscopic system in office hysteroscopy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61551511

Enrollment

144

Registered

2026-07-31

Start date

2025-11-15

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient diagnostic or operative office hysteroscopy due to suspected intra-uterine pathology Signs and Symptoms

Interventions

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 rando

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Feasibility and procedural completion rate measured using the successful completion of the hysteroscopic procedure without switching devices or aborting at intraoperative / immediately after the procedure	—

Secondary

Measure	Time frame
Intraoperative parameters, patient tolerability, and operator satisfaction measured using a 5-point Likert scale rated by the surgeon at post-procedure;Procedural duration measured using total procedure time measured in minutes at the end of the study;Patient pain perception measured using a Visual Analog Scale (VAS, 0–10) at immediately post-procedure;Fluid management and setup measured using setup time and volume of distension medium used at the end of the study;Adverse events measured using incidence of intraoperative and immediate post-procedural complications (e.g., vasovagal reactions, bleeding, uterine perforation) at intraoperatively and immediately post-procedure prior to discharge	—

Measure

Time frame

Intraoperative parameters, patient tolerability, and operator satisfaction measured using a 5-point Likert scale rated by the surgeon at post-procedure;Procedural duration measured using total procedure time measured in minutes at the end of the study;Patient pain perception measured using a Visual Analog Scale (VAS, 0–10) at immediately post-procedure;Fluid management and setup measured using setup time and volume of distension medium used at the end of the study;Adverse events measured using incidence of intraoperative and immediate post-procedural complications (e.g., vasovagal reactions, bleeding, uterine perforation) at intraoperatively and immediately post-procedure prior to discharge

—

Countries

Italy

Contacts

Public ContactPasquale Florio

pasqualemario.florio@uslcentro.toscana.it+39 0573 351423

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026