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Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study)

Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system (Prospective randomized single-blind parallel group comparison study) - Intra- and postoperative clinical evaluation for hysteroscopic surgery with the TRUCLEAR system

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019649
Enrollment
120
Registered
2015-11-05
Start date
2015-11-19
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Submucous myoma Endometrial polyp

Interventions

Hysteroscopic surgery performed with TRUCLEAR system Hysteroscopic surgery performed with conventional Resectoscopy

Sponsors

Teikyo University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients who have required hysteroscopic myomectomy or polypectomy 2. Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement in a format approved by the institution site

Exclusion criteria

Exclusion criteria: 1. Patients with submucous myoma larger than 2 cm in diameter 2. Patients with FIGO type 2 submucous myoma 3. Patients who have received hysteroscopic myomectomy or polypectomy before 4. Patients with uterus bipartitus 5. Patients with intrauterine adhesion 6. Patients with endometrial carcinoma or suspected endometrial carcinoma 7. Patients who are judged ineligible by the principal investigator or sub-investigators

Design outcomes

Primary

MeasureTime frame
Operating time

Secondary

MeasureTime frame
1. Removal success 2. Fluid deficit 3. Convenience with technique 4. Insertion time during surgery 5. Visibility of Operation Field 6. Recurrence of chief complaint 7. Adverse event 8. Pain, expectation, and satisfaction evaluated by patient

Countries

Japan

Contacts

Public ContactAkira Tsuchiya

University Hospital, Mizonokuchi, Teikyo University School of Medicine Obstetrics and Gynecology

tsuchiya@med.teikyo-u.ac.jp044-844-3333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026