Vaginal or Laparoscopic HysterectomyNCT05332132
Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy
A study testing Heracure Device in people with Vaginal or Laparoscopic Hysterectomy, run by Heracure Medical Ltd. at 1 site in Israel.
Trial summary
Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal or Laparoscopic Hysterectomy
- What is being tested?
- Heracure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is undergoing hysterectomy due to benign gynecologic disease
Who cannot join
- Subject is not suspected of malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Aisa Kaizler, 097471041, asia.kaizler@clalit.org.il
About this study
Official title: Evaluation of the Heracure Device for Hysterectomy
Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
Read the detailed description
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
- Conditions
- Vaginal or Laparoscopic Hysterectomy
- Being tested
- Heracure Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heracure DeviceDevice
Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study)
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine Morcellation of Uteri Post-Surgery | Experimental | Intrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study) Receives: Device: Heracure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device or procedure related Adverse Event (AE)
Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline.
Measured: Intra-operation
Secondary outcomes (1)
Device Success
Device Success defined as the ability to reduce uterus size/circumference and the time required for performing the morcellation procedure
Measured: Intra-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start18 Apr 2022
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Vaginal or Laparoscopic HysterectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heracure Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gal Meister, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332132
- Sponsor's protocol ID
- 202019038
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pomeranz M, Schonman R, Yagur Y, Tamir Yaniv R, Klein Z, Daykan Y. An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study. PLoS One. 2023 Mar 17;18(3):e0282149. doi: 10.1371/journal.pone.0282149. eCollection 2023.
PubMed 36930660
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Heracure Device for Hysterectomy
- ClinicalTrials.gov ID
- NCT05332132
- Acronym / sponsor ID
- 202019038
- Conditions
- Vaginal or Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Heracure Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Apr 2022 (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.
Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
Detailed description
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrauterine Morcellation of Uteri Post-Surgery | Experimental | Device: Heracure DeviceIntrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is undergoing hysterectomy due to benign gynecologic disease
Key exclusion criteria (1 listed)
- Subject is not suspected of 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 |
|---|---|---|
| Heracure DeviceIntrauterine Morcellation of Uteri Post-Surgery (Ex Vivo Study) | Device | Intrauterine Morcellation of Uteri Post-Surgery |
Primary outcome
Device or procedure related Adverse Event (AE)
Time frame: Intra-operation
Adverse Event defined as uterine perforation at the end of procedure, assessed by inflating the uterus with saline.
1 secondary outcome
Device Success
Time frame: Intra-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 36930660Pomeranz M, Schonman R, Yagur Y, Tamir Yaniv R, Klein Z, Daykan Y. An intrauterine cavity morcellator: A novel approach to high volume uterus morcellation. Ex-vivo study. PLoS One. 2023 Mar 17;18(3):e0282149. doi: 10.1371/journal.pone.0282149. eCollection 2023.
Related trials for Vaginal or Laparoscopic Hysterectomy
Recruiting
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
Hysterectomy, Vaginal
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.
Gal Meister study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heracure Device in people with Vaginal or Laparoscopic Hysterectomy, run by Heracure Medical Ltd. 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gal Meister (0549011128, galmeist1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device or procedure related Adverse Event (AE) (time frame: Intra-operation). 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 NCT05332132, 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 25 May 2022.