Early Pregnancy FailurePhase 4Triple MNCT03212352

Comparing Two Medical Treatments for Early Pregnancy Failure.

A Phase 4 study testing Mifepristone and Misoprostol in people with Early Pregnancy Failure, run by Radboud University Medical Center at 13 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Read more about this study

Who is it for?: Ages 16 years and older, women only
Conditions the study is for: Early Pregnancy Failure
What is being tested?: Mifepristone and Misoprostol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 342 participants
Where: 13 sitesNetherlands
Study dates: 27 Jun 2018to 16 Mar 2020
Phase: Phase 4
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 16 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Early pregnancy failure, 6-14 weeks postmenstrual with
a crown-rump length ≥ 6mm and no cardiac activity OR
a crown-rump length <6mm and no fetal growth at least one week later OR
a gestational sac with absent embryonic pole for at least one week.
At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age
Intra-uterine pregnancy

Show all 11Show fewer

Women aged above 16 years
Hemodynamic stable patient
No signs of infection
No signs of incomplete abortion
No contraindications for mifepristone or misoprostol

Who cannot join

Patient does not meet inclusion criteria, discovered after randomization
Inability to give informed consent
Known clotting disorder or use of anticoagulants
Known risk factors for, or presence of, a cardiovascular disease
Language barrier

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Netherlands13 sites

OLVG
Amsterdam
Rijnstate
Arnhem, Gelderland, 6815 AD
Amphia Hospital
Breda
Catharina Hospital
Eindhoven
Martini Hospital
Groningen
Zuyderland Medical Centre
Heerlen
St. Antonius Hospital
Nieuwegein
Radboud University Medical Centre
Nijmegen, Gelderland, 6500 HB
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532 SZ
Laurentius Hosptial
Roermond
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
Haaglanden Medical Centre
The Hague
VieCuri Medical Centre
Venlo

Other trials in Netherlands

About this study

Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

Read the detailed description

This study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). The trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled.

Women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). The investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre.

After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined

Conditions: Early Pregnancy Failure
Being tested: Mifepristone, Misoprostol
Keywords: miscarriage, mifepristone, misoprostol, medical treatment, patient satisfaction, abortifacient agents
Medical subject headings: Abortion, Spontaneous, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MifepristoneDrug
Also called Mifegyne
Adding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg.
MisoprostolDrug
Also called Cytotec
Regular treatment with Misoprostol 800 mcg.

Study groups in NCT03212352
Study group	Role	What they receive
Misoprostol	Placebo comparator	Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive an oral placebo. Receives: Drug: Misoprostol
Misoprostol and Mifepristone	Experimental	Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg). Receives: Drug: Mifepristone; Drug: Misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete evacuation
Whether or not complete evacuation (total endometrial thickness <15 mm) has been acquired will be assessed through ultrasonography.
Measured: six weeks after initial treatment

Secondary outcomes (6)

patient satisfaction
To assess how satisfied patient are with the treatment they underwent. Patient satisfaction with treatment will be measured using The Client Satisfaction Questionnaire (CSQ-8, digital)
Measured: At baseline, day four, two and six weeks after treatment
complications
How many and which complications have occured?
Measured: six weeks after treatment
side effects
Which side effects have patients experienced and to what degree?
Measured: six weeks after treatment
costs
To evaluate which medical treatment strategy is cost-effective, volumes of health care consumed will additionally be measured prospectively alongside the clinical trial together with cost associated with productivity losses. Costs of medical interventions (direct costs) and costs resulting from productivity loss (indirect costs) will be taken into account. Resource uses will be recorded in the case report forms. Standardized unit costs will be calculated using the Dutch manual for costing in economic evaluations and standardised costs.
Measured: up to six weeks after treatment
Overall quality of health, as experienced by the patient.
To measure the quality of the health status of the patients, a validated so-called health-related quality of life (HRQoL) instrument will be used: the Short Form 36 health survey
Measured: At baseline, day four, and two and six weeks after initial treatment.
Overall quality of health, as experienced by the patient.
To measure the quality of the health status of the patients,a validated so-called health-related quality of life (HRQoL) instrument will be used: the EuroQol-5D.
Measured: At baseline, day four, and two and six weeks after initial treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 201816 Mar 2020

First posted11 Jul 2017
Study start27 Jun 2018
Primary completion23 Jan 2020
Study completion16 Mar 2020

Why it stopped: Advised by DSMB based on interim-analysis, highly significant difference.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Early Pregnancy FailureStudies of the same condition, open and under way.
More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance).
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03212352
Sponsor's protocol ID: 62449
Acronym: Triple M
Status last verified: Sep 2019
First submitted: 2 Jul 2017
Last updated: 1 May 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Graziosi GC, Mol BW, Reuwer PJ, Drogtrop A, Bruinse HW. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: a randomized trial. Hum Reprod. 2004 Aug;19(8):1894-9. doi: 10.1093/humrep/deh344. Epub 2004 Jun 10.
PubMed 15192065
You JH, Chung TK. Expectant, medical or surgical treatment for spontaneous abortion in first trimester of pregnancy: a cost analysis. Hum Reprod. 2005 Oct;20(10):2873-8. doi: 10.1093/humrep/dei163. Epub 2005 Jun 24.
PubMed 15979988
Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
PubMed 24082042
Lemmers M, Verschoor MA, Hooker AB, Opmeer BC, Limpens J, Huirne JA, Ankum WM, Mol BW. Dilatation and curettage increases the risk of subsequent preterm birth: a systematic review and meta-analysis. Hum Reprod. 2016 Jan;31(1):34-45. doi: 10.1093/humrep/dev274. Epub 2015 Nov 2.
PubMed 26534897
Soulat C, Gelly M. [Immediate complications of surgical abortion]. J Gynecol Obstet Biol Reprod (Paris). 2006 Apr;35(2):157-62. doi: 10.1016/s0368-2315(06)76389-x. French.
PubMed 16575361
Niinimaki M, Jouppila P, Martikainen H, Talvensaari-Mattila A. A randomized study comparing efficacy and patient satisfaction in medical or surgical treatment of miscarriage. Fertil Steril. 2006 Aug;86(2):367-72. doi: 10.1016/j.fertnstert.2005.12.072. Epub 2006 Jun 9.
PubMed 16764872
Neilson JP, Hickey M, Vazquez J. Medical treatment for early fetal death (less than 24 weeks). Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002253. doi: 10.1002/14651858.CD002253.pub3.
PubMed 16855990
van den Berg J, Gordon BBM, Snijders MPML, Vandenbussche FPHA, Coppus SFPJ. The added value of mifepristone to non-surgical treatment regimens for uterine evacuation in case of early pregnancy failure: a systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:18-26. doi: 10.1016/j.ejogrb.2015.09.027. Epub 2015 Sep 30.
PubMed 26461963
Lemmers M, Verschoor MAC, Oude Rengerink K, Naaktgeboren C, Bossuyt PM, Huirne JAF, Janssen IAH, Radder C, Klinkert ER, Langenveld J, van der Voet L, Siemens FF, Bongers MY, van Hooff MH, van der Ploeg M, Sjors FPJ, Coppus SFPJ, Ankum WM, Mol BWJ; MisoREST study group. MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:83-89. doi: 10.1016/j.ejogrb.2017.01.019. Epub 2017 Jan 27.
PubMed 28209537
Lemmers M, Verschoor MA, Oude Rengerink K, Naaktgeboren C, Opmeer BC, Bossuyt PM, Huirne JA, Janssen CA, Radder C, Klinkert ER, Langenveld J, Catshoek R, Van der Voet L, Siemens F, Geomini P, Van Hooff MH, Van der Ploeg JM, Coppus SF, Ankum WM, Mol BW; MisoREST study group. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial. Hum Reprod. 2016 Nov;31(11):2421-2427. doi: 10.1093/humrep/dew221. Epub 2016 Sep 2.
PubMed 27591236
Say L, Kulier R, Gulmezoglu M, Campana A. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database Syst Rev. 2005 Jan 25;2002(1):CD003037. doi: 10.1002/14651858.CD003037.pub2.
PubMed 15674900
Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
PubMed 22071804
Maria B, Chaneac M, Stampf F, Ulmann A. [Early pregnancy interruption using an antiprogesterone steroid: Mifepristone (RU 486)]. J Gynecol Obstet Biol Reprod (Paris). 1988;17(8):1089-94. French.
PubMed 3235788
Grimes DA, Mishell DR Jr, Shoupe D, Lacarra M. Early abortion with a single dose of the antiprogestin RU-486. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1307-12. doi: 10.1016/0002-9378(88)90361-4.
PubMed 2454578
van den Berg J, van den Bent JM, Snijders MP, de Heus R, Coppus SF, Vandenbussche FP. Sequential use of mifepristone and misoprostol in treatment of early pregnancy failure appears more effective than misoprostol alone: a retrospective study. Eur J Obstet Gynecol Reprod Biol. 2014 Dec;183:16-9. doi: 10.1016/j.ejogrb.2014.10.010. Epub 2014 Oct 14.
PubMed 25461345

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Early Pregnancy Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
ClinicalTrials.gov ID: NCT03212352
Acronym / sponsor ID: Triple M / 62449
Conditions: Early Pregnancy Failure
Keywords: miscarriage, mifepristone, misoprostol, medical treatment, patient satisfaction, abortifacient agents
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Advised by DSMB based on interim-analysis, highly significant difference.
Enrolment: 342 participants (actual)
Lead sponsor: Radboud University Medical CenterUniversity, hospital or other
Collaborators: Innovatiefonds Zorgverzekeraars, Canisius-Wilhelmina Hospital
Study start: 27 Jun 2018 (actual)
Primary completion: 23 Jan 2020 (actual)
Study completion: 16 Mar 2020 (actual)
First posted: 11 Jul 2017 (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.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

Detailed description

After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance).

Arm	Type	Receives
Misoprostol	Placebo comparator	Drug: MisoprostolBefore medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive an oral placebo.
Misoprostol and Mifepristone	Experimental	Drug: Mifepristone, Drug: MisoprostolBefore medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).

Who may qualify

Ages: 16 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Early pregnancy failure, 6-14 weeks postmenstrual with
a crown-rump length ≥ 6mm and no cardiac activity OR
a crown-rump length <6mm and no fetal growth at least one week later OR
a gestational sac with absent embryonic pole for at least one week.

Key exclusion criteria (5 listed)

Patient does not meet inclusion criteria, discovered after randomization
Inability to give informed consent
Known clotting disorder or use of anticoagulants
Known risk factors for, or presence of, a cardiovascular disease
Language barrier

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
MifepristoneAlso: MifegyneAdding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg.	Drug	Misoprostol and Mifepristone
MisoprostolAlso: CytotecRegular treatment with Misoprostol 800 mcg.	Drug	Misoprostol, Misoprostol and Mifepristone

Primary outcome

Complete evacuation
Time frame: six weeks after initial treatment
Whether or not complete evacuation (total endometrial thickness <15 mm) has been acquired will be assessed through ultrasonography.

6 secondary outcomes

patient satisfaction
Time frame: At baseline, day four, two and six weeks after treatment
complications
Time frame: six weeks after treatment
side effects
Time frame: six weeks after treatment
costs
Time frame: up to six weeks after treatment
Overall quality of health, as experienced by the patient.
Time frame: At baseline, day four, and two and six weeks after initial treatment.
Overall quality of health, as experienced by the patient.
Time frame: At baseline, day four, and two and six weeks after initial treatment.

Results and safety

The study was stopped early (reason given: Advised by DSMB based on interim-analysis, highly significant difference.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
Background: PubMed 15192065Graziosi GC, Mol BW, Reuwer PJ, Drogtrop A, Bruinse HW. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: a randomized trial. Hum Reprod. 2004 Aug;19(8):1894-9. doi: 10.1093/humrep/deh344. Epub 2004 Jun 10.
Background: PubMed 15979988You JH, Chung TK. Expectant, medical or surgical treatment for spontaneous abortion in first trimester of pregnancy: a cost analysis. Hum Reprod. 2005 Oct;20(10):2873-8. doi: 10.1093/humrep/dei163. Epub 2005 Jun 24.
Background: PubMed 24082042Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
Background: PubMed 26534897Lemmers M, Verschoor MA, Hooker AB, Opmeer BC, Limpens J, Huirne JA, Ankum WM, Mol BW. Dilatation and curettage increases the risk of subsequent preterm birth: a systematic review and meta-analysis. Hum Reprod. 2016 Jan;31(1):34-45. doi: 10.1093/humrep/dev274. Epub 2015 Nov 2.
Background: PubMed 16575361Soulat C, Gelly M. [Immediate complications of surgical abortion]. J Gynecol Obstet Biol Reprod (Paris). 2006 Apr;35(2):157-62. doi: 10.1016/s0368-2315(06)76389-x. French.
Background: PubMed 16764872Niinimaki M, Jouppila P, Martikainen H, Talvensaari-Mattila A. A randomized study comparing efficacy and patient satisfaction in medical or surgical treatment of miscarriage. Fertil Steril. 2006 Aug;86(2):367-72. doi: 10.1016/j.fertnstert.2005.12.072. Epub 2006 Jun 9.
Background: PubMed 16855990Neilson JP, Hickey M, Vazquez J. Medical treatment for early fetal death (less than 24 weeks). Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002253. doi: 10.1002/14651858.CD002253.pub3.
Background: PubMed 26461963van den Berg J, Gordon BBM, Snijders MPML, Vandenbussche FPHA, Coppus SFPJ. The added value of mifepristone to non-surgical treatment regimens for uterine evacuation in case of early pregnancy failure: a systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:18-26. doi: 10.1016/j.ejogrb.2015.09.027. Epub 2015 Sep 30.
Background: PubMed 28209537Lemmers M, Verschoor MAC, Oude Rengerink K, Naaktgeboren C, Bossuyt PM, Huirne JAF, Janssen IAH, Radder C, Klinkert ER, Langenveld J, van der Voet L, Siemens FF, Bongers MY, van Hooff MH, van der Ploeg M, Sjors FPJ, Coppus SFPJ, Ankum WM, Mol BWJ; MisoREST study group. MisoREST: Surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: A cohort study. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:83-89. doi: 10.1016/j.ejogrb.2017.01.019. Epub 2017 Jan 27.
Background: PubMed 27591236Lemmers M, Verschoor MA, Oude Rengerink K, Naaktgeboren C, Opmeer BC, Bossuyt PM, Huirne JA, Janssen CA, Radder C, Klinkert ER, Langenveld J, Catshoek R, Van der Voet L, Siemens F, Geomini P, Van Hooff MH, Van der Ploeg JM, Coppus SF, Ankum WM, Mol BW; MisoREST study group. MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial. Hum Reprod. 2016 Nov;31(11):2421-2427. doi: 10.1093/humrep/dew221. Epub 2016 Sep 2.
Background: PubMed 15674900Say L, Kulier R, Gulmezoglu M, Campana A. Medical versus surgical methods for first trimester termination of pregnancy. Cochrane Database Syst Rev. 2005 Jan 25;2002(1):CD003037. doi: 10.1002/14651858.CD003037.pub2.
Background: PubMed 22071804Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
The management of early pregnancy loss. Royal College of Obstetricians and Gynaecologists, Green-top Guideline No. 25.Link provided by the sponsor.
Zwangerschapsafbreking tot 24 weken. Richtlijn Nederlandse Vereniging voor Obstetrie \& Gynaecologie.Link provided by the sponsor.
Cytotec UK SPC (Summary of Product Characteristics).Link provided by the sponsor.
Mifegyne 200 mg tablets: Summary of Product Characteristics (SmPC)Link provided by the sponsor.
Mifepristone - MifegyneLink provided by the sponsor.
Erytrocytenimmunisatie en zwangerschap. Versie 2.1, 2009.Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Frank P. Vandenbussche, Prof. Dr. study director

Radboud University Medical Center

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mifepristone and Misoprostol in people with Early Pregnancy Failure, run by Radboud University Medical Center at 13 sites in Netherlands.

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 11 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Advised by DSMB based on interim-analysis, highly significant difference.). Results are not available in the source record.

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?

Complete evacuation (time frame: six weeks after initial treatment). 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 NCT03212352, which also lists 31 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 1 May 2020.