Surgical TechniqueNCT01688310
A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
A study testing Gomco Clamp with Tissue Adhesive and Open surgical circumcision in people with Surgical Technique, run by Universidade Católica de Moçambique at 1 site in Mozambique.
Trial summary
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Technique
- What is being tested?
- Gomco Clamp with Tissue Adhesive and Open surgical circumcision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMozambique
- Study dates
- Aug 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men > 18 years of age requesting circumcision
- No penile anatomical abnormalities or infections
- Able to provide informed consent to participate
- Willing to participate in follow-up visits
Who cannot join
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
Read the detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention and Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV infection would be prevented between now and 2025 for every seven circumcisions performed in Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13% among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where the study will take place, are currently circumcised.
In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and PEPFAR to more effectively scale-up circumcision services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
The investigators propose a randomized controlled trial (RCT) comparing this minimally-invasive circumcision technique to the open surgical technique:
- Gomco clamp with tissue adhesive: 100 men
- Open surgical circumcision: 100 men
The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on its use in Africa. Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in circumcision in boys. The investigators refer to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these two independently-validated components have only been coupled in observational studies among men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT among adult men. The open surgical method is PEPFAR-approved and will serve as the control intervention.
Population: Men > 18 years of age who desire male circumcision Sample size: 200 (100 men in each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14 days and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.
- Conditions
- Surgical Technique
- Being tested
- Gomco Clamp with Tissue Adhesive, Open surgical circumcision
- Keywords
- Gomco clamp instrument, Tissue adhesive, Open surgical circumcision, Minimally-invasive circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gomco Clamp with Tissue AdhesiveProcedure or surgery
According to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC.
Open surgical circumcisionProcedure or surgery
The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Open surgical circumcision | Active comparator | Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common. Receives: Procedure: Open surgical circumcision |
| Gomco clamp with tissue adhesive | Experimental | Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups. Receives: Procedure: Gomco Clamp with Tissue Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Duration
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
Measured: 1 year
Secondary outcomes (6)
Difficulty in Learning and Performing Technique
Evaluated by doctor survey, 5 point Likert scale:
- Gomco technique is much easier
- Gomco technique is easier
- Neutral
- Open surgical technique is easier
- Open surgical technique is much easier
Measured: 1 year
Time Required for Healing
Time required for healing
Measured: Within 6 weeks after surgery
Direct Costs
the cost of labor, supplies and equipment
Measured: Within 6 weeks after surgery
Pain Experienced
Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)
Measured: 2 days after surgery
Overall Patient Satisfaction
Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
Measured: Within 6 weeks after surgery
Cosmetic Result
Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).
Measured: Within 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Surgical TechniqueStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Católica de Moçambique
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Catholic University of Mozambique
- Responsible party
- Principal investigator, Dr. Peter Millard, Universidade Católica de Moçambique
- Investigators
- Peter Millard, MD, PhD, Principal investigator, Universidade Catholic de Mozambique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688310
- Sponsor's protocol ID
- PRO11080657
- Status last verified
- Jun 2013
- First submitted
- 27 Aug 2012
- Last updated
- 10 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
PubMed 17321311Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.
PubMed 11798403Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.
PubMed 12478073Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.
PubMed 15832878Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.
PubMed 15763713Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.
PubMed 15788922Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77. doi: 10.2471/blt.08.051482.
PubMed 18797642Kim HH, Goldstein M. High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.
PubMed 19107114Lane V, Vajda P, Subramaniam R. Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26.
PubMed 19707772Elmore JM, Smith EA, Kirsch AJ. Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6. doi: 10.1016/j.urology.2007.07.002.
PubMed 17991565Kaye JD, Kalisvaart JF, Cuda SP, Elmore JM, Cerwinka WH, Kirsch AJ. Sutureless and scalpel-free circumcision--more rapid, less expensive and better? J Urol. 2010 Oct;184(4 Suppl):1758-62. doi: 10.1016/j.juro.2010.03.081. Epub 2010 Aug 21.
PubMed 20728122World Health Organization. Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007
World Health Organization. Manual for Male Circumcision under Local Anaesthesia. 2009.
World Health Organization. Manual for early infant male circumcision under local anaesthesia. 2010.
World Health Organization. Framework for Clinical Evaluation of Devices for Adult Male Circumcision. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
- ClinicalTrials.gov ID
- NCT01688310
- Acronym / sponsor ID
- PRO11080657
- Conditions
- Surgical Technique
- Keywords
- Gomco clamp instrument, Tissue adhesive, Open surgical circumcision, Minimally-invasive circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidade Católica de MoçambiqueUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Catholic University of Mozambique
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Posted 10 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
Detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention and Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV infection would be prevented between now and 2025 for every seven circumcisions performed in Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13% among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where the study will take place, are currently circumcised.
In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and PEPFAR to more effectively scale-up circumcision services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
The investigators propose a randomized controlled trial (RCT) comparing this minimally-invasive circumcision technique to the open surgical technique:
- Gomco clamp with tissue adhesive: 100 men
- Open surgical circumcision: 100 men
The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on its use in Africa. Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in circumcision in boys. The investigators refer to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these two independently-validated components have only been coupled in observational studies among men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT among adult men. The open surgical method is PEPFAR-approved and will serve as the control intervention.
Population: Men > 18 years of age who desire male circumcision Sample size: 200 (100 men in each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14 days and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgical circumcision | Active comparator | Procedure: Open surgical circumcisionOpen surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common. |
| Gomco clamp with tissue adhesive | Experimental | Procedure: Gomco Clamp with Tissue AdhesiveCoupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men > 18 years of age requesting circumcision
- No penile anatomical abnormalities or infections
- Able to provide informed consent to participate
- Willing to participate in follow-up visits
Key exclusion criteria (4 listed)
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
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 |
|---|---|---|
| Gomco Clamp with Tissue AdhesiveAccording to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC. | Procedure or surgery | Gomco clamp with tissue adhesive |
| Open surgical circumcisionThe World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure. | Procedure or surgery | Open surgical circumcision |
Primary outcome
Intraoperative Duration
Time frame: 1 year
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
6 secondary outcomes
Difficulty in Learning and Performing Technique
Time frame: 1 year
Time Required for Healing
Time frame: Within 6 weeks after surgery
Direct Costs
Time frame: Within 6 weeks after surgery
Pain Experienced
Time frame: 2 days after surgery
Overall Patient Satisfaction
Time frame: Within 6 weeks after surgery
Cosmetic Result
Time frame: Within 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17321311Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
- Background: PubMed 11798403Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.
- Background: PubMed 12478073Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.
- Background: PubMed 15832878Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.
- Background: PubMed 15763713Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.
- Background: PubMed 15788922Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.
- Background: PubMed 18797642Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77. doi: 10.2471/blt.08.051482.
- Background: PubMed 19107114Kim HH, Goldstein M. High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.
- Background: PubMed 19707772Lane V, Vajda P, Subramaniam R. Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26.
- Background: PubMed 17991565Elmore JM, Smith EA, Kirsch AJ. Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6. doi: 10.1016/j.urology.2007.07.002.
- Background: PubMed 20728122Kaye JD, Kalisvaart JF, Cuda SP, Elmore JM, Cerwinka WH, Kirsch AJ. Sutureless and scalpel-free circumcision--more rapid, less expensive and better? J Urol. 2010 Oct;184(4 Suppl):1758-62. doi: 10.1016/j.juro.2010.03.081. Epub 2010 Aug 21.
- BackgroundWorld Health Organization. Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007
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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.
Peter Millard, MD, PhD principal investigator
Universidade Catholic de Mozambique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gomco Clamp with Tissue Adhesive and Open surgical circumcision in people with Surgical Technique, run by Universidade Católica de Moçambique at 1 site in Mozambique.
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 4 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 10 Sep 2013. 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 Mozambique. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative Duration (time frame: 1 year). 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 NCT01688310, which also lists 16 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 10 Sep 2013.