EndometriosisOPINENCT04318275
Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis
An observational study of Endometriosis, run by Biofourmis Singapore Pte Ltd. at 7 sites in 3 countries.
Trial summary
This study aims to explore a novel objective measurement for endometriosis-related pain. A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 90 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 6 Nov 2020to 22 Feb 2022
- 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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: 124 study participants, aged between 21 to 50 years old, female, who is confirmed diagnosis of endometriosis.
Who may be able to join
- Able to give a written Informed Consent Form.
- Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting)
- Female patients aged ≥ 21 and < 50 years.
- Patient who meets either A or B or both in the following criteria: A. Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation.
- Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
- Patient who meets either A or B in the following criteria:
Show all 9Show fewer
- Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have regular menses (i.e. 21-38 days) within 38 days prior to the study participation.
- Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period
- Patient has a moderate to severe endometriosis- associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation
Who cannot join
- Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
- Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
- Patient has more than five surgical histories in pelvic area.
- Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
- Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
- Patient has a planned surgery during the study.
Show all 9Show fewer
- Patient had a surgery within 4 weeks prior to the study participation.
- Patient has a planned trip overseas during the study participation.
- Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Singapore3 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
KK Women's and Children's Hospital
Singapore, 229899
United States2 sites
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Taiwan2 sites
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients With Endometriosis (OPINE)
This study aims to explore a novel objective measurement for endometriosis-related pain. A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, pain beyond the pelvis, endometriosis diagnosis, or severity of pain using operative findings and a standardized classification system.
Read the detailed description
BACKGROUND ON ENDOMETRIOSIS
A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, and pain beyond the pelvis, and endometriosis diagnosis and severity using operative findings and a standardized classification system.
Historically, pain has been measured using subjective scales to determine the presence of pain and its severity. Common scales include the numeric rating scale (NRS), visual analog scale (VAS), and visual response scale (VRS). While this is important information, self-reporting is a problematic metric for both diagnostic and research purposes as it depends on pain history, cognitive and behavioral factors, and can vary over time. Other measures used in clinical practice, such as the Biberoglu and Behrman (B\&B) score, incorporate both patient and clinician assessments of pain. However, patients describe symptomatology and gynecologists evaluate tenderness and induration during physical examination with an exceedingly high risk of bias and inconsistent reproducibility. Over the past few years, significant advances have been made in the development of valid biomarkers or surrogate markers for the presence and severity of pain. Measurement of various physiology parameters like heart rate, heart rate variability and electrodermal activity have shown to be associated with the presence of pain and can aid clinical interpretation.
STUDY RATIONALE
Several ratings, such as the numeric rating scale (NRS) are mainly used in clinical trials to determine the presence and severity of pain associated with endometriosis. Patient Reported Outcomes (PRO) such as NRS can be problematic as they are subjective, containing recall bias, and can vary over time. Thus, a more accurate and objective measurement of pain is needed to evaluate the efficacy of treatment with pain associated with endometriosis.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance between Pain Index and NRS scores during the study period. (Categorised into none, mild, moderate and severe pain)
Pain Index will be generated via vital sign collected from subjects and processed by Biofourmis's propriety algorithm. Both pain index and NRS will be categorised into None (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain.
Concordance will be measured using unweighted Kappa Statistic for multiple categories with 95% CI. Percentage agreement between the categories will be also calculated by taking the number of concordant pairs divided by the total number of pain episodes.
Measured: 12 weeks
Secondary outcomes (1)
The correlation between 11-point Pain Index (0-10) and 11-point NRS score (0-10).
The generated Pain Index will be classified into 11 points (0-10) in accordance with the raw NRS score.
Correlation between the 11-point Pain Index and raw NRS score will be measured using Spearman correlation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start6 Nov 2020
- Primary completion28 Oct 2021
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofourmis Singapore Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Maulik Majmudar, M.D., Study chair, Biofourmis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318275
- Sponsor's protocol ID
- CT004-AMY004JG
- Acronym
- OPINE
- Status last verified
- May 2022
- First submitted
- 22 Dec 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fauconnier A, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implications. Hum Reprod Update. 2005 Nov-Dec;11(6):595-606. doi: 10.1093/humupd/dmi029. Epub 2005 Sep 19.
PubMed 16172113Ballard KD, Seaman HE, de Vries CS, Wright JT. Can symptomatology help in the diagnosis of endometriosis? Findings from a national case-control study--Part 1. BJOG. 2008 Oct;115(11):1382-91. doi: 10.1111/j.1471-0528.2008.01878.x. Epub 2008 Aug 19.
PubMed 18715240Cox L, Ayers S, Nala K, Penny J. Chronic pelvic pain and quality of life after laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2007 Jun;132(2):214-9. doi: 10.1016/j.ejogrb.2006.04.020. Epub 2006 May 30.
PubMed 16730874Kang SB, Chung HH, Lee HP, Lee JY, Chang YS. Impact of diagnostic laparoscopy on the management of chronic pelvic pain. Surg Endosc. 2007 Jun;21(6):916-9. doi: 10.1007/s00464-006-9047-1. Epub 2006 Nov 14.
PubMed 17103271Ballard K, Lane H, Hudelist G, Banerjee S, Wright J. Can specific pain symptoms help in the diagnosis of endometriosis? A cohort study of women with chronic pelvic pain. Fertil Steril. 2010 Jun;94(1):20-7. doi: 10.1016/j.fertnstert.2009.01.164. Epub 2009 Apr 1.
PubMed 19342028Hsu AL, Sinaii N, Segars J, Nieman LK, Stratton P. Relating pelvic pain location to surgical findings of endometriosis. Obstet Gynecol. 2011 Aug;118(2 Pt 1):223-230. doi: 10.1097/AOG.0b013e318223fed0.
PubMed 21775836Renner SP, Boosz AS, Burghaus S, Maihofner C, Beckmann MW, Fasching PA, Jud SM. Visual pain mapping in endometriosis. Arch Gynecol Obstet. 2012 Sep;286(3):687-93. doi: 10.1007/s00404-012-2369-4. Epub 2012 May 9.
PubMed 22569716Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.
PubMed 9130884Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
PubMed 25180023Yong PJ, Williams C, Bodmer-Roy S, Ezeigwe C, Zhu S, Arion K, Ambacher K, Yosef A, Wong F, Noga H, Britnell S, Yager H, Bedaiwy MA, Brotto LA, Albert AY, Lisonkova S, Allaire C. Prospective Cohort of Deep Dyspareunia in an Interdisciplinary Setting. J Sex Med. 2018 Dec;15(12):1765-1775. doi: 10.1016/j.jsxm.2018.10.005. Epub 2018 Nov 13.
PubMed 30446474Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014 Apr;101(4):927-35. doi: 10.1016/j.fertnstert.2014.02.012. Epub 2014 Mar 13.
PubMed 24630080Rotondi MA, Donner A. A confidence interval approach to sample size estimation for interobserver agreement studies with multiple raters and outcomes. J Clin Epidemiol. 2012 Jul;65(7):778-84. doi: 10.1016/j.jclinepi.2011.10.019. Epub 2012 May 4.
PubMed 22560852Schliep KC, Mumford SL, Peterson CM, Chen Z, Johnstone EB, Sharp HT, Stanford JB, Hammoud AO, Sun L, Buck Louis GM. Pain typology and incident endometriosis. Hum Reprod. 2015 Oct;30(10):2427-38. doi: 10.1093/humrep/dev147. Epub 2015 Aug 11.
PubMed 26269529
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients With Endometriosis (OPINE)
- ClinicalTrials.gov ID
- NCT04318275
- Acronym / sponsor ID
- OPINE / CT004-AMY004JG
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Biofourmis Singapore Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 23 Mar 2020 (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.
This study aims to explore a novel objective measurement for endometriosis-related pain. A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, pain beyond the pelvis, endometriosis diagnosis, or severity of pain using operative findings and a standardized classification system.
Detailed description
BACKGROUND ON ENDOMETRIOSIS
A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, and pain beyond the pelvis, and endometriosis diagnosis and severity using operative findings and a standardized classification system.
Historically, pain has been measured using subjective scales to determine the presence of pain and its severity. Common scales include the numeric rating scale (NRS), visual analog scale (VAS), and visual response scale (VRS). While this is important information, self-reporting is a problematic metric for both diagnostic and research purposes as it depends on pain history, cognitive and behavioral factors, and can vary over time. Other measures used in clinical practice, such as the Biberoglu and Behrman (B\&B) score, incorporate both patient and clinician assessments of pain. However, patients describe symptomatology and gynecologists evaluate tenderness and induration during physical examination with an exceedingly high risk of bias and inconsistent reproducibility. Over the past few years, significant advances have been made in the development of valid biomarkers or surrogate markers for the presence and severity of pain. Measurement of various physiology parameters like heart rate, heart rate variability and electrodermal activity have shown to be associated with the presence of pain and can aid clinical interpretation.
STUDY RATIONALE
Several ratings, such as the numeric rating scale (NRS) are mainly used in clinical trials to determine the presence and severity of pain associated with endometriosis. Patient Reported Outcomes (PRO) such as NRS can be problematic as they are subjective, containing recall bias, and can vary over time. Thus, a more accurate and objective measurement of pain is needed to evaluate the efficacy of treatment with pain associated with endometriosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 124 study participants, aged between 21 to 50 years old, female, who is confirmed diagnosis of endometriosis.
Key inclusion criteria (9 listed)
- Able to give a written Informed Consent Form.
- Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting)
- Female patients aged ≥ 21 and < 50 years.
- Patient who meets either A or B or both in the following criteria: A. Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation.
- Patient who meets either A or B in the following criteria:
Key exclusion criteria (9 listed)
- Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
- Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
- Patient has more than five surgical histories in pelvic area.
- Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
- Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concordance between Pain Index and NRS scores during the study period. (Categorised into none, mild, moderate and severe pain)
Time frame: 12 weeks
Pain Index will be generated via vital sign collected from subjects and processed by Biofourmis's propriety algorithm. Both pain index and NRS will be categorised into None (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain. Concordance will be measured using unweighted Kappa Statistic for multiple categories with 95% CI. Percentage agreement between the categories will be also calculated by taking the number of concordant pairs divided by the total number of pain episodes.
1 secondary outcome
The correlation between 11-point Pain Index (0-10) and 11-point NRS score (0-10).
Time frame: 12 weeks
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 19 May 2022.
- Background: PubMed 16172113Fauconnier A, Chapron C. Endometriosis and pelvic pain: epidemiological evidence of the relationship and implications. Hum Reprod Update. 2005 Nov-Dec;11(6):595-606. doi: 10.1093/humupd/dmi029. Epub 2005 Sep 19.
- Background: PubMed 18715240Ballard KD, Seaman HE, de Vries CS, Wright JT. Can symptomatology help in the diagnosis of endometriosis? Findings from a national case-control study--Part 1. BJOG. 2008 Oct;115(11):1382-91. doi: 10.1111/j.1471-0528.2008.01878.x. Epub 2008 Aug 19.
- Background: PubMed 16730874Cox L, Ayers S, Nala K, Penny J. Chronic pelvic pain and quality of life after laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2007 Jun;132(2):214-9. doi: 10.1016/j.ejogrb.2006.04.020. Epub 2006 May 30.
- Background: PubMed 17103271Kang SB, Chung HH, Lee HP, Lee JY, Chang YS. Impact of diagnostic laparoscopy on the management of chronic pelvic pain. Surg Endosc. 2007 Jun;21(6):916-9. doi: 10.1007/s00464-006-9047-1. Epub 2006 Nov 14.
- Background: PubMed 19342028Ballard K, Lane H, Hudelist G, Banerjee S, Wright J. Can specific pain symptoms help in the diagnosis of endometriosis? A cohort study of women with chronic pelvic pain. Fertil Steril. 2010 Jun;94(1):20-7. doi: 10.1016/j.fertnstert.2009.01.164. Epub 2009 Apr 1.
- Background: PubMed 21775836Hsu AL, Sinaii N, Segars J, Nieman LK, Stratton P. Relating pelvic pain location to surgical findings of endometriosis. Obstet Gynecol. 2011 Aug;118(2 Pt 1):223-230. doi: 10.1097/AOG.0b013e318223fed0.
- Background: PubMed 22569716Renner SP, Boosz AS, Burghaus S, Maihofner C, Beckmann MW, Fasching PA, Jud SM. Visual pain mapping in endometriosis. Arch Gynecol Obstet. 2012 Sep;286(3):687-93. doi: 10.1007/s00404-012-2369-4. Epub 2012 May 9.
- Background: PubMed 9130884Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.
- Background: PubMed 25180023Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
- Background: PubMed 30446474Yong PJ, Williams C, Bodmer-Roy S, Ezeigwe C, Zhu S, Arion K, Ambacher K, Yosef A, Wong F, Noga H, Britnell S, Yager H, Bedaiwy MA, Brotto LA, Albert AY, Lisonkova S, Allaire C. Prospective Cohort of Deep Dyspareunia in an Interdisciplinary Setting. J Sex Med. 2018 Dec;15(12):1765-1775. doi: 10.1016/j.jsxm.2018.10.005. Epub 2018 Nov 13.
- Background: PubMed 24630080Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis: a committee opinion. Fertil Steril. 2014 Apr;101(4):927-35. doi: 10.1016/j.fertnstert.2014.02.012. Epub 2014 Mar 13.
- Background: PubMed 22560852Rotondi MA, Donner A. A confidence interval approach to sample size estimation for interobserver agreement studies with multiple raters and outcomes. J Clin Epidemiol. 2012 Jul;65(7):778-84. doi: 10.1016/j.jclinepi.2011.10.019. Epub 2012 May 4.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruitingObservational study
Clinical Impact of Ultrasound Diagnosis in Bowel Endometriosis
Endometriosis, Endometriosis Rectum
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
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.
Maulik Majmudar, M.D. study chair
Biofourmis Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Biofourmis Singapore Pte Ltd. at 7 sites in 3 countries.
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 9 inclusion and 9 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 19 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 7 sites in Singapore, United States, Taiwan. 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?
The concordance between Pain Index and NRS scores during the study period. (Categorised into none, mild, moderate and severe pain) (time frame: 12 weeks). 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 NCT04318275, which also lists 13 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 19 May 2022.