Uterine FibroidsLUSTORNCT01750008
Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions
A study testing Global Fibroid Ablation and Myomectomy in people with Uterine Fibroids and Myomas, run by Acessa Health, Inc. at 1 site in Germany.
Trial summary
The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids, Myomas
- What is being tested?
- Global Fibroid Ablation and Myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Jun 2018
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are ≥ 18 years old and menstruating
- Have symptomatic uterine fibroids
- Have a uterine size ≤16 gestational weeks as determined by pelvic exam
- Have fibroids that are less than 10 cm in any diameter
- Desire uterine conservation
- Have had a normal Papanicolaou test (PAP smear) (i.e. PAP I or PAP II) at the latest pre-study examination and no longer than 36 months before study entry.
- Are willing and able to comply with all study tests, procedures, and assessment tools
- Are capable of providing informed consent.
Who cannot join
- Have contraindications for laparoscopic surgery and/or general anesthesia.
- Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
- Patients requiring major elective concomitant procedures (e.g., hernia repair, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
- Are pregnant or lactating
- Have taken any depot Gonadotropin-releasing hormone (GnRh agonist within three months prior to the screening procedures
- Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least ten days prior to treatment
Show all 16Show fewer
- Have chronic pelvic pain not due to uterine fibroids
- Have known or suspected endometriosis or adenomyosis
- Have active or history of pelvic inflammatory disease
- Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
- Have had pelvic radiation
- Have a non-uterine pelvic mass over 3 cm
- Have a cervical myoma
- Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
- In the medical judgment of the investigator should not participate in the study
- Are not willing to be randomized to treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.
- Conditions
- Uterine Fibroids, Myomas
- Being tested
- Global Fibroid Ablation, Myomectomy
- Keywords
- Symptomatic Uterine Fibroids, Menorrhagia, Heavy Bleeding, Myomas, Radiofrequency Ablation, RFA, Leiomyoma, Fibroids
- Medical subject headings
- Leiomyoma, Myoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Fibroid AblationProcedure or surgery
Also called Halt Procedure, Acessa Procedure
MyomectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Global Fibroid Ablation | Other | Global Fibroid Ablation Receives: Procedure: Global Fibroid Ablation |
| Laparoscopic Myomectomy | Other | Myomectomy via laparoscopy Receives: Procedure: Myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.
Measured: From admission to the duration of hospital stay, an expected average of 3 days
Secondary outcomes (7)
Compare and contrast post-treatment readmission and reintervention rate
Compare incidence of post discharge readmission within 1 month of procedure and rate of reintervention for fibroid-related symptoms up to 60 months post procedure
Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Compare and Contrast peri and post procedural safety including procedural blood loss and complications
Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast recovery rate
Compare how many days it takes to return-to-work and to normal activities of daily living.
Measured: Discharge from hospital up to an average of 5 weeks post treatment
Compare and Contrast post-treatment changes in fibroid symptom severity.
Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast post-treatment patient satisfaction
Compare the overall subject treatment outcome and satisfaction evaluation
Measured: 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and Contrast post-treatment changes in menstrual status.
Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Measured: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Compare and Contrast post-treatment changes concerning health-related quality-of-life.
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Measured: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acessa Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Brucker, MD, Principal investigator, University of Tubingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750008
- Sponsor's protocol ID
- CP-00-0018
- Acronym
- LUSTOR
- Status last verified
- Nov 2018
- First submitted
- 11 Dec 2012
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.
PubMed 11814511Twijnstra AR, Kolkman W, Trimbos-Kemper GC, Jansen FW. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):487-92. doi: 10.1016/j.jmig.2010.03.010. Epub 2010 May 14.
PubMed 20471917Viswanathan M, Hartmann K, McKoy N, Stuart G, Rankins N, Thieda P, Lux LJ, Lohr KN. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep). 2007 Jul;(154):1-122.
PubMed 18288885Holzer A, Jirecek ST, Illievich UM, Huber J, Wenzl RJ. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006 May;102(5):1480-4. doi: 10.1213/01.ane.0000204321.85599.0d.
PubMed 16632830Parker WH, Iacampo K, Long T. Uterine rupture after laparoscopic removal of a pedunculated myoma. J Minim Invasive Gynecol. 2007 May-Jun;14(3):362-4. doi: 10.1016/j.jmig.2006.10.024.
PubMed 17478371Banas T, Klimek M, Fugiel A, Skotniczny K. Spontaneous uterine rupture at 35 weeks' gestation, 3 years after laparoscopic myomectomy, without signs of fetal distress. J Obstet Gynaecol Res. 2005 Dec;31(6):527-30. doi: 10.1111/j.1447-0756.2005.00331.x.
PubMed 16343253Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.
PubMed 17943348Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012 Jun;35(3):530-6. doi: 10.1007/s00270-011-0228-5. Epub 2011 Jul 20.
PubMed 21773858Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
PubMed 21345435Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.
PubMed 21043553Hartung J, Knapp G. On tests of the overall treatment effect in meta-analysis with normally distributed responses. Stat Med. 2001 Jun 30;20(12):1771-82. doi: 10.1002/sim.791.
PubMed 11406840Levine DJ, Harris M, Berman JM, Macer J, Abbott K, Lee BB. Leiomyoma assessment by intra-abdominal ultrasound compared to preoperative ultrasound and preoperative magnetic imaging. J Minim Invasive Gynecol. 2011;18(suppl):S1.
Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.
PubMed 21481151U.S. Valuation of the EuroQoL EQ-5D Health States. December 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gove/rice/EQ5Dproj.htm
Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962.
PubMed 23635746
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial
- ClinicalTrials.gov ID
- NCT01750008
- Acronym / sponsor ID
- LUSTOR / CP-00-0018
- Conditions
- Uterine Fibroids, Myomas
- Keywords
- Symptomatic Uterine Fibroids, Menorrhagia, Heavy Bleeding, Myomas, Radiofrequency Ablation, RFA, Leiomyoma, Fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Acessa Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Dec 2012 (estimated)
- 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 purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
| Arm | Type | Receives |
|---|---|---|
| Global Fibroid Ablation | Other | Procedure: Global Fibroid AblationGlobal Fibroid Ablation |
| Laparoscopic Myomectomy | Other | Procedure: MyomectomyMyomectomy via laparoscopy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are ≥ 18 years old and menstruating
- Have symptomatic uterine fibroids
- Have a uterine size ≤16 gestational weeks as determined by pelvic exam
- Have fibroids that are less than 10 cm in any diameter
- Desire uterine conservation
Key exclusion criteria (16 listed)
- Have contraindications for laparoscopic surgery and/or general anesthesia.
- Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
- Patients requiring major elective concomitant procedures (e.g., hernia repair, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
- Are pregnant or lactating
- Have taken any depot Gonadotropin-releasing hormone (GnRh agonist within three months prior to the screening procedures
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 |
|---|---|---|
| Global Fibroid AblationAlso: Halt Procedure, Acessa Procedure | Procedure or surgery | Global Fibroid Ablation |
| Myomectomy | Procedure or surgery | Laparoscopic Myomectomy |
Primary outcome
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
Time frame: From admission to the duration of hospital stay, an expected average of 3 days
Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.
7 secondary outcomes
Compare and contrast post-treatment readmission and reintervention rate
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Compare and Contrast peri and post procedural safety including procedural blood loss and complications
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast recovery rate
Time frame: Discharge from hospital up to an average of 5 weeks post treatment
Compare and Contrast post-treatment changes in fibroid symptom severity.
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast post-treatment patient satisfaction
Time frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and Contrast post-treatment changes in menstrual status.
Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Compare and Contrast post-treatment changes concerning health-related quality-of-life.
Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
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 20 Nov 2018.
- Background: PubMed 11814511Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.
- Background: PubMed 20471917Twijnstra AR, Kolkman W, Trimbos-Kemper GC, Jansen FW. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):487-92. doi: 10.1016/j.jmig.2010.03.010. Epub 2010 May 14.
- Background: PubMed 18288885Viswanathan M, Hartmann K, McKoy N, Stuart G, Rankins N, Thieda P, Lux LJ, Lohr KN. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep). 2007 Jul;(154):1-122.
- Background: PubMed 16632830Holzer A, Jirecek ST, Illievich UM, Huber J, Wenzl RJ. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006 May;102(5):1480-4. doi: 10.1213/01.ane.0000204321.85599.0d.
- Background: PubMed 17478371Parker WH, Iacampo K, Long T. Uterine rupture after laparoscopic removal of a pedunculated myoma. J Minim Invasive Gynecol. 2007 May-Jun;14(3):362-4. doi: 10.1016/j.jmig.2006.10.024.
- Background: PubMed 16343253Banas T, Klimek M, Fugiel A, Skotniczny K. Spontaneous uterine rupture at 35 weeks' gestation, 3 years after laparoscopic myomectomy, without signs of fetal distress. J Obstet Gynaecol Res. 2005 Dec;31(6):527-30. doi: 10.1111/j.1447-0756.2005.00331.x.
- Background: PubMed 17943348Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.
- Background: PubMed 21773858Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012 Jun;35(3):530-6. doi: 10.1007/s00270-011-0228-5. Epub 2011 Jul 20.
- Background: PubMed 21345435Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
- Background: PubMed 21043553Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.
- Background: PubMed 11406840Hartung J, Knapp G. On tests of the overall treatment effect in meta-analysis with normally distributed responses. Stat Med. 2001 Jun 30;20(12):1771-82. doi: 10.1002/sim.791.
- BackgroundLevine DJ, Harris M, Berman JM, Macer J, Abbott K, Lee BB. Leiomyoma assessment by intra-abdominal ultrasound compared to preoperative ultrasound and preoperative magnetic imaging. J Minim Invasive Gynecol. 2011;18(suppl):S1.
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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.
Sara Brucker, MD principal investigator
University of Tubingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Fibroid Ablation and Myomectomy in people with Uterine Fibroids and Myomas, run by Acessa Health, Inc. at 1 site in Germany.
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 8 inclusion and 16 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 20 Nov 2018. 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 Germany. 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?
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA (time frame: From admission to the duration of hospital stay, an expected average of 3 days). 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 NCT01750008, which also lists 23 linked publications.
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 20 Nov 2018.