Evaluating a single-use disposable hysteroscopic system in office hysteroscopy

ISRCTN	ISRCTN61551511
DOI	https://doi.org/10.1186/ISRCTN61551511
Sponsor	Azienda Usl Toscana Centro
Funder	Azienda USL Toscana Centro

Submission date: 22/07/2026
Registration date: 31/07/2026
Last edited: 30/07/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Pasquale Florio
Public, Principal investigator, Scientific

Department of Maternal and Fetal Medicine, Section of Obstetrics & Gynecology, "S. Jacopo" Hospital, Pistoia
Pistoia
51100
Italy

ORCID ID	0009-0004-8915-9460
Phone	+39 0573 351423
Email	pasqualemario.florio@uslcentro.toscana.it

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Device feasibility, Treatment
Participant information sheet	49969_PIS.pdf
Scientific title	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
Study objectives	The primary objective of this study is to evaluate the feasibility, clinical efficacy, and safety of a novel single-use disposable hysteroscopic operating system (RedPine) compared with standard reusable hysteroscopic equipment in an outpatient office setting. Secondary objectives include evaluating operator satisfaction, procedural duration, fluid management efficiency, equipment setup time, and patient tolerability/pain perception during diagnostic and operative office hysteroscopy.
Ethics approval(s)	Approved 10/11/2025, Ethics Committee for Clinical Trials – Tuscany Centre Local Health Authority Section (Comitato Etico per la Sperimentazione Clinica - Sezione Azienda U.S.L. Toscana Centro) (Presidio Ospedaliero di Pistoia, Via della Vergine 3, Pistoia, 51100, Italy; +39 0573 351103; giorgio.nencioni@uslcentro.toscana.it), ref: P25/059
Health condition(s) or problem(s) studied	Outpatient diagnostic or operative office hysteroscopy due to suspected intra-uterine pathology
Intervention	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.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	RedPine single-use disposable hysteroscopic operating system, standard reusable hysteroscopic operating system
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/01/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Female
Target sample size at registration	144
Total final enrolment	144
Key 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
Key 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
Date of first enrolment	15/11/2025
Date of final enrolment	30/01/2026

Locations

Countries of recruitment

Italy

Study participating centre

Ospedale San Jacopo - USL Toscana Centro, Pistoia

Via Ciliegiole, 1
Pistoia
51100
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			30/07/2026	No	Yes
Protocol file			30/07/2026	No	No

Additional files

49969_PIS.pdf: Participant information sheet
49969_Protocol.pdf: Protocol file

Editorial Notes

22/07/2026: Study’s existence confirmed by the Ethics Committee for Clinical Trials – Tuscany Centre Local Health Authority Section (Comitato Etico per la Sperimentazione Clinica - Sezione Azienda U.S.L. Toscana Centro), Italy.