Operative Hysteroscopic Using a Tissue Removal Device for Surgical Management of Early Pregnancy Loss Without Anesthesia - A Pilot Study

November 4, 2026 updated by: Noam Smorgick Rosenba, Shaare Zedek Medical Center

This small pilot study will assess whether early pregnancy loss (miscarriage) can be treated in an outpatient clinic using hysteroscopy without anesthesia, how well patients tolerate the procedure, and what complications occur. Hysteroscopy uses a small-diameter instrument with a camera to see inside the womb (uterus). A tissue removal device allows the doctor to remove pregnancy tissue while watching it directly.

The study will enroll 20 patients with pregnancy loss at up to 8 weeks of pregnancy who have chosen surgical treatment over medical treatment or expectant management. All participants will receive the study procedure; there is no comparison group. Researchers will record whether the pregnancy tissue is completely removed, pain during and shortly after the procedure, procedure duration, and complications. If the procedure cannot be completed or a participant asks to stop because of discomfort, an alternative procedure using suction aspiration (i.e., the traditional procedure for surgical abortion) will be offered the same day under sedation.

Participants will be invited to a follow-up visit 4-6 weeks later. This visit will include an ultrasound scan and diagnostic hysteroscopy to check for remaining pregnancy tissue or scar tissue inside the womb. The findings will provide an initial assessment of this approach and help guide future research.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, single-arm, non-blinded pilot study will evaluate the feasibility, patient tolerability, and safety of office-based operative hysteroscopy using a tissue removal device for surgical management of early pregnancy loss without anesthesia. The study will enroll 20 participants at Shaare Zedek Medical Center. There will be no comparison group.

Hysteroscopy allows direct visualization of the uterine cavity and targeted removal of pregnancy tissue. This study will assess whether this approach can be completed in an outpatient setting without anesthesia and will provide preliminary information on procedural success, pain, and complications.

Patients presenting to the gynecological emergency department with early pregnancy loss who have chosen surgical management will be offered participation. Eligible participants must be older than 18 years, have a gestational age of up to 8 weeks calculated from the first day of the last menstrual period, and have a gestational sac measuring less than 20 mm in diameter on pelvic ultrasound. Participants must be able to provide informed consent and read and write Hebrew. Patients with heavy vaginal bleeding, incomplete miscarriage, signs of infection or suspected septic miscarriage, previous medical or surgical treatment during the current pregnancy, or a history of intrauterine adhesions will be excluded.

Following clinical and ultrasound assessment and written informed consent, the study procedure will be scheduled within one week of the initial emergency department assessment. Experienced hysteroscopic surgeons will perform the procedure in the outpatient hysteroscopy suite without anesthesia. Participants will also provide separate informed consent for operative hysteroscopy. At the surgeon's discretion, selected participants may receive misoprostol for cervical preparation, as specified in the protocol.

Pregnancy tissue will be removed under direct hysteroscopic visualization using the mini-Elite TruClear tissue removal system with the mini-soft-tissue shaver. Normal saline will be used to distend the uterine cavity. Removed tissue will be submitted for pathological examination. Procedure duration, estimated blood loss, fluid deficit, and intraoperative complications will be recorded. Maximum pain during the procedure will be assessed using a 10-cm visual analogue scale.

Procedural success will be defined as complete hysteroscopic removal of pregnancy tissue while the participant remains comfortable. Incomplete removal because of limited visibility or termination at the participant's request because of discomfort will be classified as an unsuccessful procedure. These participants will be offered standard vacuum aspiration under sedation in the operating room or manual vacuum aspiration without anesthesia in the clinic. The chosen alternative procedure will be completed the same day.

After the procedure, participants will be observed in the clinic recovery room for 30 minutes. Vital signs and postoperative bleeding will be assessed, and pain will be measured 5 minutes after the procedure using the same visual analogue scale. Oral analgesia will be offered and administered on request, and its use will be documented. Participants who remain clinically well after observation will be discharged home.

All participants will be invited to a follow-up visit 4-6 weeks after the procedure. Follow-up will include assessment of postoperative adverse events, including excessive pain, excessive bleeding, fever, urgent medical consultations, and emergency department visits. Office hysteroscopy and transvaginal pelvic ultrasound will be performed to assess for intrauterine adhesions and retained pregnancy tissue. Abnormal findings will be documented, and further management will be recommended according to standard clinical criteria.

Study outcomes will include the proportions of successful and unsuccessful procedures, procedure duration, intraoperative and postoperative complications, the proportion of participants with a pain score greater than 6 during or after the procedure, and the rates of intrauterine adhesions and retained pregnancy tissue at follow-up. Intraoperative complications assessed will include uterine perforation, estimated blood loss greater than 250 mL, and fluid deficit greater than 2,500 mL. Postoperative complications assessed will include fever, vaginal bleeding requiring a repeat procedure, and readmission within one month.

No formal sample size calculation is planned because this is an exploratory pilot study. The sample of 20 participants is intended to provide an initial assessment of feasibility, tolerability, and observed complications rather than to test a definitive efficacy hypothesis. Findings will be interpreted in light of the small sample size, particularly its limited ability to assess uncommon adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age up to 8 weeks of gestation (calculated from the first day of the last menstrual period) and a gestational sac measuring < 20 mm in diameter on pelvic ultrasound.
  • Age > 18 years
  • Patients able to provide informed consent and to read/write Hebrew

Exclusion Criteria:

  • Heavy vaginal bleeding or diagnosis of incomplete miscarriage (incomplete abortion)
  • Signs of infection and/or suspected septic abortion
  • Previous medical or surgical treatment in the current pregnancy
  • History of intrauterine adhesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Operative Hysteroscopy

Surgical evacuation by office operative hysteroscopy
Device: Operative hysteroscopy using the tissue removal device

Use of operative hysteroscopy (Mini-elite Truclear) in the office etting for removal of early pregnancy loss for

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: 1 day

Proportions of successful and unsuccessful procedures
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: 1 day

Measurement of duration of the procedures in minutes
1 day
Intraoperative pain
Time Frame: During the procedure

Maximal pain measured by 10 cm VAS
During the procedure
Postoperative pain
Time Frame: 5 minutes after the procedure

Maximal pain measured by 10 cm VAS
5 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0421-26-SZMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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