Uterine PolypNCT05722028
Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
An observational study of Uterine Polyp and Retained Products of Conception, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Polyp, Retained Products of Conception
- What is being tested?
- hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Women who have been diagnosed with a benign pathology (polyp or retained products of conception) in diagnostic hysteroscopy and are accepted for surgical hysteroscopy in a clinical setting (without anesthesia) for its removal.
Who may be able to join
- Diagnosis of polyp or retained products of conception in diagnostic hysteroscopy.
- Medical need to remove the finding according to accepted criteria.
- Patient's consent to the removal of the finding in a procedure without anesthesia.
- Patient's consent to participate in the study.
Who cannot join
- Any indication for performing the procedure under anesthesia in an operating room, such as:
- Medical background requiring operation in an operating room.
- Personal / mental background requiring procedure under general anesthesia.
- Cervical stenosis
- Previous failure to remove the finding in a procedure without anesthesia
- Lack of response to performing the operation without anesthesia
- The lack of response to participate in the study
- A known diagnosis of malignancy from a previous sample of the polyp or endometrium
Trial locations and contacts
1 site in 1 country.
About this study
Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception (RPOC) with a diameter of ¬6 mm.
Objective: To assess the success rate and intraoperative pain of patients undergoing operative hysteroscopy without anesthesia with the TRD (TruClear Elite Mini-Hysteroscope) for removal of endometrial polyps or RPOC.
Methods: Prospective observational study. Participation in the study was offered to patients diagnosed with uterine polyps or RPOC on office diagnostic hysteroscopy. The patients filled out a digital questionnaire before and after the operation. A successful procedure was defined as complete hysteroscopic removal of the uterine pathology using the TruClear system. Oral 400 mcg misoprostol 12 hours before the procedure was prescribed for cervical ripening.
- Conditions
- Uterine Polyp, Retained Products of Conception
- Being tested
- hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopyProcedure or surgery
Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.
| Study group | Role | What they receive |
|---|---|---|
| Patients with benign uterine findings (polyp / retained products of conception) | Female patients undergoing diagnostic hysteroscopy with a diagnosis of uterine polyp or retained products of conception. These patients are then invited to a surgical office procedure without anaesthesia to remove these findings. Receives: Procedure: hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure completed successfully
Was the procedure completed - yes/no
Measured: Immediately after procedure
Secondary outcomes (4)
Prevalence of VAS (pain scale) > 5 during procedure
VAS (Visual analogue scale 0-10, most painful 10) grading by the patient
Measured: Immediately after procedure
Prevalence of VAS (pain scale) > 5, five minutes after procedure
VAS (Visual analogue scale 0-10, most painful 10) grading by the patient
Measured: 5 minutes after procedure
Acceptable procedure by the patient
Was the procedure acceptable by the patient (1-4 when 1 is most acceptable)
Measured: 5 minutes after procedure
Recommended procedure by the patient
Would the patient recommend her acquittance the procedure in this outline (1-5, most recommended 5) aquitance (1-5)
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Aug 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine PolypStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maayan Gal, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722028
- Sponsor's protocol ID
- 123456
- Status last verified
- Sep 2024
- First submitted
- 29 Jan 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Mor M, Kochav MG, Ezratty J, Dovev MN, Eisenberg N, Smorgick N. Feasibility of Office-Based Operative Hysteroscopy by a Tissue Removal System Without Anesthesia. J Minim Invasive Gynecol. 2024 Aug;31(8):667-673. doi: 10.1016/j.jmig.2024.05.005. Epub 2024 May 11.
PubMed 38740128
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia
- ClinicalTrials.gov ID
- NCT05722028
- Acronym / sponsor ID
- 123456
- Conditions
- Uterine Polyp, Retained Products of Conception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Feb 2023 (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.
Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception (RPOC) with a diameter of ¬6 mm.
Objective: To assess the success rate and intraoperative pain of patients undergoing operative hysteroscopy without anesthesia with the TRD (TruClear Elite Mini-Hysteroscope) for removal of endometrial polyps or RPOC.
Methods: Prospective observational study. Participation in the study was offered to patients diagnosed with uterine polyps or RPOC on office diagnostic hysteroscopy. The patients filled out a digital questionnaire before and after the operation. A successful procedure was defined as complete hysteroscopic removal of the uterine pathology using the TruClear system. Oral 400 mcg misoprostol 12 hours before the procedure was prescribed for cervical ripening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with benign uterine findings (polyp / retained products of conception) | – | Procedure: hysteroscopyFemale patients undergoing diagnostic hysteroscopy with a diagnosis of uterine polyp or retained products of conception. These patients are then invited to a surgical office procedure without anaesthesia to remove these findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who have been diagnosed with a benign pathology (polyp or retained products of conception) in diagnostic hysteroscopy and are accepted for surgical hysteroscopy in a clinical setting (without anesthesia) for its removal.
Key inclusion criteria (4 listed)
- Diagnosis of polyp or retained products of conception in diagnostic hysteroscopy.
- Medical need to remove the finding according to accepted criteria.
- Patient's consent to the removal of the finding in a procedure without anesthesia.
- Patient's consent to participate in the study.
Key exclusion criteria (8 listed)
- Any indication for performing the procedure under anesthesia in an operating room, such as:
- The lack of response to participate in the study
- A known diagnosis of malignancy from a previous sample of the polyp or endometrium
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 |
|---|---|---|
| hysteroscopySurgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception. | Procedure or surgery | Patients with benign uterine findings (polyp / retained products of conception) |
Primary outcome
Procedure completed successfully
Time frame: Immediately after procedure
Was the procedure completed - yes/no
4 secondary outcomes
Prevalence of VAS (pain scale) > 5 during procedure
Time frame: Immediately after procedure
Prevalence of VAS (pain scale) > 5, five minutes after procedure
Time frame: 5 minutes after procedure
Acceptable procedure by the patient
Time frame: 5 minutes after procedure
Recommended procedure by the patient
Time frame: 5 minutes after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 38740128Mor M, Kochav MG, Ezratty J, Dovev MN, Eisenberg N, Smorgick N. Feasibility of Office-Based Operative Hysteroscopy by a Tissue Removal System Without Anesthesia. J Minim Invasive Gynecol. 2024 Aug;31(8):667-673. doi: 10.1016/j.jmig.2024.05.005. Epub 2024 May 11.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Uterine Polyp and Retained Products of Conception, run by Assaf-Harofeh 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 27 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure completed successfully (time frame: Immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722028, which also lists 1 linked publication.
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 27 Sep 2024.