Retained Products of ConceptionNCT07875985
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
An observational study of Retained Products of Conception and Hysteroscopy, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The goal of this observational study is to identify predictors of successful removal of benign intrauterine pathology using a mini-resectoscope during office operative hysteroscopy without anesthesia in adult women with suspected or diagnosed endometrial polyps or retained products of conception up to 2.5 cm in size. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Retained Products of Conception, Hysteroscopy, Endometrial Polyp Benign
- What is being tested?
- Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women presenting to the hysteroscopy clinic within the Gynecology Department at Shaare Zedek Medical Center who are referred for evaluation and management of suspected or confirmed benign intrauterine pathology. Patients are evaluated in an outpatient hysteroscopy setting and may be offered office operative hysteroscopy using a mini-resectoscope as part of routine clinical care when considered appropriate by the treating hysteroscopist
Who may be able to join
- Female participants aged 18 years or older
- Suspected or confirmed endometrial polyp or retained products of conception identified by ultrasound
- Intrauterine lesion measuring up to 2.5 cm in maximal diameter
- Up to two endometrial polyps or retained products of conception lesions within the uterine cavity
- Considered suitable candidates for office operative hysteroscopy without anesthesia by the treating physician
- Willingness to undergo hysteroscopic treatment without anesthesia
- Ability to provide informed consent
Who cannot join
- Patients with medical, psychological, or personal conditions requiring operative hysteroscopy in an operating room under general anesthesia Known cervical stenosis
- Prior failure of office operative hysteroscopy without anesthesia Refusal or lack of willingness to undergo the procedure without anesthesia
- Refusal or lack of willingness to participate in the study
- Known diagnosis of endometrial malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Department of Gynecology, Shaare Zedek Medical Center
Jerusalem
Ayala Hirsch, Doctor, +97226555562, Ayala46@gmail.com
About this study
Official title: Predictors of Successful Removal of Benign Intrauterine Pathologies Using a Mini-Resectoscope During Office Operative Hysteroscopy Without Anesthesia: A Prospective Observational Study
The goal of this observational study is to identify predictors of successful removal of benign intrauterine pathology using a mini-resectoscope during office operative hysteroscopy without anesthesia in adult women with suspected or diagnosed endometrial polyps or retained products of conception up to 2.5 cm in size.
The main questions it aims to answer are:
Read more
- Which demographic, gynecologic, clinical, and hysteroscopic factors are associated with successful completion of office operative hysteroscopy using a mini-resectoscope without anesthesia?
- Which factors are associated with severe pain during the procedure, defined as a Visual Analog Scale (VAS) score greater than 7?
- Is prolonged procedure duration (>3 minutes) associated with higher intraoperative pain scores?
- Are there differences in success rates between procedures performed for endometrial polyps versus retained products of conception?
Participants will:
- Undergo office operative hysteroscopy without anesthesia using the Miniresectoscope device for removal of endometrial polyps or retained products of conception.
- Provide demographic, obstetric, gynecologic, and medical history information before the procedure.
- Have intraoperative hysteroscopic and surgical characteristics recorded, including cervical stenosis, uterine orientation, lesion size and location, lesion morphology, and procedure duration.
- Complete pain assessments using the Visual Analog Scale (VAS) during the procedure and 5 minutes after the procedure.
- Be evaluated for procedural success, defined as complete removal of the intrauterine pathology.
Read the detailed description
Office hysteroscopy has significantly evolved over the last decade with the development of smaller operative hysteroscopic systems that allow treatment of intrauterine pathology without cervical dilation, sedation, or general anesthesia. These advances support the transition from conventional operating-room hysteroscopy toward office-based "see-and-treat" procedures.
Despite increasing adoption of office operative hysteroscopy, patient selection remains insufficiently standardized. While many patients tolerate office procedures well, a subset experience severe pain, inability to complete the procedure, or technical difficulties related to cervical access, lesion characteristics, or prolonged operative duration. Current literature provides limited data regarding predictors of procedural success and patient tolerability, particularly in procedures performed using mini-resectoscope technology.
The mini-resectoscope system used in this study was designed specifically for office operative hysteroscopy and combines a reduced outer diameter with the ability to perform electrosurgical resection of intrauterine pathology. Compared with conventional resectoscopes, the smaller caliber may reduce the need for cervical dilation and improve feasibility in outpatient settings. However, evidence regarding optimal patient selection for this technology remains limited.
The present study focuses on women with suspected or confirmed benign intrauterine pathology, specifically endometrial polyps and retained products of conception measuring up to 2.5 cm. These lesions are among the most common indications for operative hysteroscopy and are frequently encountered in outpatient hysteroscopy clinics.
A major objective of the study is to identify demographic, gynecologic, clinical, and hysteroscopic characteristics associated with successful completion of office operative hysteroscopy without anesthesia. Variables evaluated in the study were selected based on previously suggested associations with procedural difficulty or pain perception. These include parity, menopausal status, prior cervical procedures, history of cesarean delivery, prior hysteroscopic interventions, uterine orientation, cervical stenosis, lesion morphology, lesion vascularity, and operative duration.
Pain assessment is an important component of the study because procedural pain remains one of the primary limitations of office operative hysteroscopy. Pain severity will be assessed using the Visual Analog Scale (VAS), a validated and widely used instrument for procedural pain evaluation. Both intraoperative pain and early postoperative pain will be recorded to better characterize immediate patient tolerability.
The study is designed as a prospective observational single-arm investigation performed in a dedicated outpatient hysteroscopy clinic. All procedures will be performed by experienced hysteroscopists using a standardized office-based approach without anesthesia. Procedure completion, technical difficulty, operative duration, and causes of incomplete procedures will be systematically documented.
The investigators hypothesize that successful office treatment can be achieved in the majority of appropriately selected patients, while severe pain will remain limited to a minority of cases. The study additionally aims to evaluate whether prolonged operative duration is associated with increased pain scores and whether pathology type influences procedural feasibility.
Identification of predictors associated with successful and well-tolerated office hysteroscopy may contribute to the development of evidence-based patient selection criteria for office operative hysteroscopy using mini-resectoscope systems. Improved selection algorithms may reduce unnecessary exposure to general anesthesia, improve patient counseling, optimize outpatient workflow, and support wider implementation of minimally invasive office-based hysteroscopic treatment strategies.
- Conditions
- Retained Products of Conception, Hysteroscopy, Endometrial Polyp Benign, Endometrial Polyp, Endometrial Polyps, Retained Products After Miscarriage
- Being tested
- Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
- Keywords
- hysteroscopy, Mini-resectoscope, see and treat, hysteroscopic polypectomy, Retained products of conception, Endometrial polyp, Visual Analog Scale
- Medical subject headings
- Abortion, Incomplete, Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without AnesthesiaDevice
Office operative hysteroscopy performed without anesthesia using the Karl Storz Mini-Resectoscope system (outer diameter approximately 5.5 mm) for hysteroscopic removal of benign intrauterine pathology, including endometrial polyps and retained products of conception up to 2.5 cm in size. Procedures are performed in an outpatient hysteroscopy clinic using a see-and-treat approach without routine cervical dilation, sedation, or general anesthesia. Intraoperative procedural characteristics, procedure duration, procedural completion, and patient-reported pain scores using the Visual Analog Scale (VAS) are prospectively recorded.
| Study group | Role | What they receive |
|---|---|---|
| Office Operative Hysteroscopy With Mini-Resectoscope Without Anesthesia | Adult women with suspected or confirmed benign intrauterine pathology, including endometrial polyps or retained products of conception up to 2.5 cm in size, undergoing office operative hysteroscopy without anesthesia using a mini-resectoscope system. Participants will undergo hysteroscopic removal of the intrauterine pathology in an outpatient clinic setting and will complete pain assessment using the Visual Analog Scale (VAS) during and after the procedure. Demographic, gynecologic, clinical, hysteroscopic, and procedural variables will be prospectively collected to evaluate predictors of procedural success and pain severity Receives: Device: Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Removal of Intrauterine Pathology During Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
Procedural success defined as complete hysteroscopic removal of the intrauterine pathology (endometrial polyp or retained products of conception) using the Karl Storz Mini-Resectoscope during office operative hysteroscopy without anesthesia.
Measured: During the procedure
Comparison of Rates of Incomplete Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope According to Patient's Characteristics
The rates of incomplete office operative hysteroscopy without anesthesia will be compared according to the patient's demographic, obstetric, gynecologic, and procedural characteristics, including age, body mass index (BMI), parity, prior vaginal deliveries, prior cesarean deliveries, menopausal status, previous hysteroscopic or gynecologic procedures, cervical stenosis, uterine orientation, lesion characteristics, and procedure duration. Reasons for procedural failure, including severe pain or discomfort, bleeding impairing visualization, technical difficulty, or incomplete lesion resection, will also be documented.
Measured: During the procedure
Secondary outcomes (3)
Intraoperative Visual Analog Scale (VAS) Pain Score During Office Operative Hysteroscopy
Average Intraoperative Visual Analog Scale (VAS) Pain Score During Office Operative Hysteroscopy
Measured: During the procedure
Postoperative Pain Severity Assessed by Visual Analog Scale (VAS)
Average patient-reported pain measured 5 minutes after completion of the hysteroscopic procedure using the Visual Analog Scale (VAS; range 0-10).
Measured: 5 minutes after the procedure
Procedure Duration
Total operative time of office operative hysteroscopy using the mini-resectoscope, measured in minutes from insertion of the hysteroscope into the uterine cavity until completion of the procedure.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noam Smorgick Rosenba, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875985
- Sponsor's protocol ID
- 0133-26-SZMC
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Successful Removal of Benign Intrauterine Pathologies Using a Mini-Resectoscope During Office Operative Hysteroscopy Without Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07875985
- Acronym / sponsor ID
- 0133-26-SZMC
- Conditions
- Retained Products of Conception, Hysteroscopy, Endometrial Polyp Benign, Endometrial Polyp, Endometrial Polyps, Retained Products After Miscarriage
- Keywords
- hysteroscopy, Mini-resectoscope, see and treat, hysteroscopic polypectomy, Retained products of conception, Endometrial polyp, Visual Analog Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to identify predictors of successful removal of benign intrauterine pathology using a mini-resectoscope during office operative hysteroscopy without anesthesia in adult women with suspected or diagnosed endometrial polyps or retained products of conception up to 2.5 cm in size.
The main questions it aims to answer are:
- Which demographic, gynecologic, clinical, and hysteroscopic factors are associated with successful completion of office operative hysteroscopy using a mini-resectoscope without anesthesia?
- Which factors are associated with severe pain during the procedure, defined as a Visual Analog Scale (VAS) score greater than 7?
- Is prolonged procedure duration (>3 minutes) associated with higher intraoperative pain scores?
- Are there differences in success rates between procedures performed for endometrial polyps versus retained products of conception?
Participants will:
- Undergo office operative hysteroscopy without anesthesia using the Miniresectoscope device for removal of endometrial polyps or retained products of conception.
- Provide demographic, obstetric, gynecologic, and medical history information before the procedure.
- Have intraoperative hysteroscopic and surgical characteristics recorded, including cervical stenosis, uterine orientation, lesion size and location, lesion morphology, and procedure duration.
- Complete pain assessments using the Visual Analog Scale (VAS) during the procedure and 5 minutes after the procedure.
- Be evaluated for procedural success, defined as complete removal of the intrauterine pathology.
Detailed description
Office hysteroscopy has significantly evolved over the last decade with the development of smaller operative hysteroscopic systems that allow treatment of intrauterine pathology without cervical dilation, sedation, or general anesthesia. These advances support the transition from conventional operating-room hysteroscopy toward office-based "see-and-treat" procedures.
Despite increasing adoption of office operative hysteroscopy, patient selection remains insufficiently standardized. While many patients tolerate office procedures well, a subset experience severe pain, inability to complete the procedure, or technical difficulties related to cervical access, lesion characteristics, or prolonged operative duration. Current literature provides limited data regarding predictors of procedural success and patient tolerability, particularly in procedures performed using mini-resectoscope technology.
The mini-resectoscope system used in this study was designed specifically for office operative hysteroscopy and combines a reduced outer diameter with the ability to perform electrosurgical resection of intrauterine pathology. Compared with conventional resectoscopes, the smaller caliber may reduce the need for cervical dilation and improve feasibility in outpatient settings. However, evidence regarding optimal patient selection for this technology remains limited.
The present study focuses on women with suspected or confirmed benign intrauterine pathology, specifically endometrial polyps and retained products of conception measuring up to 2.5 cm. These lesions are among the most common indications for operative hysteroscopy and are frequently encountered in outpatient hysteroscopy clinics.
A major objective of the study is to identify demographic, gynecologic, clinical, and hysteroscopic characteristics associated with successful completion of office operative hysteroscopy without anesthesia. Variables evaluated in the study were selected based on previously suggested associations with procedural difficulty or pain perception. These include parity, menopausal status, prior cervical procedures, history of cesarean delivery, prior hysteroscopic interventions, uterine orientation, cervical stenosis, lesion morphology, lesion vascularity, and operative duration.
Pain assessment is an important component of the study because procedural pain remains one of the primary limitations of office operative hysteroscopy. Pain severity will be assessed using the Visual Analog Scale (VAS), a validated and widely used instrument for procedural pain evaluation. Both intraoperative pain and early postoperative pain will be recorded to better characterize immediate patient tolerability.
The study is designed as a prospective observational single-arm investigation performed in a dedicated outpatient hysteroscopy clinic. All procedures will be performed by experienced hysteroscopists using a standardized office-based approach without anesthesia. Procedure completion, technical difficulty, operative duration, and causes of incomplete procedures will be systematically documented.
The investigators hypothesize that successful office treatment can be achieved in the majority of appropriately selected patients, while severe pain will remain limited to a minority of cases. The study additionally aims to evaluate whether prolonged operative duration is associated with increased pain scores and whether pathology type influences procedural feasibility.
Identification of predictors associated with successful and well-tolerated office hysteroscopy may contribute to the development of evidence-based patient selection criteria for office operative hysteroscopy using mini-resectoscope systems. Improved selection algorithms may reduce unnecessary exposure to general anesthesia, improve patient counseling, optimize outpatient workflow, and support wider implementation of minimally invasive office-based hysteroscopic treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Office Operative Hysteroscopy With Mini-Resectoscope Without Anesthesia | – | Device: Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without AnesthesiaAdult women with suspected or confirmed benign intrauterine pathology, including endometrial polyps or retained products of conception up to 2.5 cm in size, undergoing office operative hysteroscopy without anesthesia using a mini-resectoscope system. Participants will undergo hysteroscopic removal of the intrauterine pathology in an outpatient clinic setting and will complete pain assessment using the Visual Analog Scale (VAS) during and after the procedure. Demographic, gynecologic, clinical, hysteroscopic, and procedural variables will be prospectively collected to evaluate predictors of procedural success and pain severity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women presenting to the hysteroscopy clinic within the Gynecology Department at Shaare Zedek Medical Center who are referred for evaluation and management of suspected or confirmed benign intrauterine pathology. Patients are evaluated in an outpatient hysteroscopy setting and may be offered office operative hysteroscopy using a mini-resectoscope as part of routine clinical care when considered appropriate by the treating hysteroscopist
Key inclusion criteria (7 listed)
- Female participants aged 18 years or older
- Suspected or confirmed endometrial polyp or retained products of conception identified by ultrasound
- Intrauterine lesion measuring up to 2.5 cm in maximal diameter
- Up to two endometrial polyps or retained products of conception lesions within the uterine cavity
- Considered suitable candidates for office operative hysteroscopy without anesthesia by the treating physician
Key exclusion criteria (4 listed)
- Patients with medical, psychological, or personal conditions requiring operative hysteroscopy in an operating room under general anesthesia Known cervical stenosis
- Prior failure of office operative hysteroscopy without anesthesia Refusal or lack of willingness to undergo the procedure without anesthesia
- Refusal or lack of willingness to participate in the study
- Known diagnosis of endometrial malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without AnesthesiaOffice operative hysteroscopy performed without anesthesia using the Karl Storz Mini-Resectoscope system (outer diameter approximately 5.5 mm) for hysteroscopic removal of benign intrauterine pathology, including endometrial polyps and retained products of conception up to 2.5 cm in size. Procedures are performed in an outpatient hysteroscopy clinic using a see-and-treat approach without routine cervical dilation, sedation, or general anesthesia. Intraoperative procedural characteristics, procedure duration, procedural completion, and patient-reported pain scores using the Visual Analog Scale (VAS) are prospectively recorded. | Device | Office Operative Hysteroscopy With Mini-Resectoscope Without Anesthesia |
Primary outcome
Number of Participants With Complete Removal of Intrauterine Pathology During Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia
Time frame: During the procedure
Procedural success defined as complete hysteroscopic removal of the intrauterine pathology (endometrial polyp or retained products of conception) using the Karl Storz Mini-Resectoscope during office operative hysteroscopy without anesthesia.
Comparison of Rates of Incomplete Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope According to Patient's Characteristics
Time frame: During the procedure
The rates of incomplete office operative hysteroscopy without anesthesia will be compared according to the patient's demographic, obstetric, gynecologic, and procedural characteristics, including age, body mass index (BMI), parity, prior vaginal deliveries, prior cesarean deliveries, menopausal status, previous hysteroscopic or gynecologic procedures, cervical stenosis, uterine orientation, lesion characteristics, and procedure duration. Reasons for procedural failure, including severe pain or discomfort, bleeding impairing visualization, technical difficulty, or incomplete lesion resection, will also be documented.
3 secondary outcomes
Intraoperative Visual Analog Scale (VAS) Pain Score During Office Operative Hysteroscopy
Time frame: During the procedure
Postoperative Pain Severity Assessed by Visual Analog Scale (VAS)
Time frame: 5 minutes after the procedure
Procedure Duration
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
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Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
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A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Products of Conception and Hysteroscopy, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noam Smorgick, MD (+97226555562, noamsm@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Removal of Intrauterine Pathology During Office Operative Hysteroscopy Using the Karl Storz Mini-Resectoscope Without Anesthesia (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.