Wound and InjuriesNPWTNCT02565043
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
A study testing RENASYS TOUCH Negative Pressure Wound Therapy System in people with Wound and Injuries and Surgical Wound Dehiscence, run by Smith & Nephew, Inc. at 2 sites in South Africa.
Trial summary
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound and Injuries, Surgical Wound Dehiscence
- What is being tested?
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Apr 2015to Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is able to understand the study and is willing to consent to the study
- The patient consents to the on-going use of their de-identified photos by the Sponsor for purposes outside of this study
- Patients must be at least 18 years old
- Males and females. If female, they must not be pregnant. If female and of reproductive age, a pregnancy test will be provided
- Patient must have an acute, sub-acute or chronic wound that would benefit from the application of topical Negative Pressure Wound Therapy (NPWT)
- Patients must have an acute or sub-acute wound requiring wound bed preparation for an expected minimum of 4 days in advance of either planned surgical closure (including delayed primary closure, flaps or grafts) or planned secondary closure, OR a chronic wound requiring wound bed preparation in advance of planned surgical closure (not secondary intention)
- The patient, or the patient's legal representative, if the patient is incapable of giving legal consent, is able to understand the trial and is willing to consent to the trial
Who cannot join
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this study previously and who [healed or] were withdrawn.
- Patients who are unable to understand the aims and objectives of the study.
- Presence of necrotic tissue, or >25% slough in the reference wound bed. Once debridement has taken place, treatment with the investigational product may proceed
- Patients whose reference wound displays evidence of extensive tunnelling or sinus tracts
- Previously confirmed and untreated osteomyelitis
Show all 16Show fewer
- Malignancy in the reference wound
- Non-enteric and unexplored Fistulas
- Presence of untreated infection in the reference wound bed (Infection must be treated with systemic antibiotics to permit inclusion in the trial and can be administered concurrently during the trial treatment regime)
- Active bleeding. Once haemostasis has been achieved, treatment with the investigational product may proceed
- Exposure of blood vessels or organs at the base of the reference wound
- Patients with a known history of poor compliance with medical treatment
- Patients who have participated in this trial previously and who healed or were withdrawn
- Patients treated on an out-patient basis who cannot continue to be treated as out-patients and/or attend the clinic for dressing changes as detailed in the treatment regimen of the study protocol
- Patients whose wounds are not suitable for treatment with intermittent therapy mode (e.g. highly exuding wounds, wounds with tunnels or undermining, wounds in difficult areas where maintaining a seal is problematic, patients who experience severe pain during intermittent therapy)
- Patients who are employees of Smith \& Nephew group companies.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Tiervlei Trail Centre
Bellville, Cape Town, 7530
Dr Matley & Partners
Claremont, Cape Town, 7708
About this study
Official title: A Prospective, Open, Multi-centre Study to Evaluate Clinical Efficacy, Functionality and Device Performance of a New Portable Negative Pressure Wound Therapy System (RENASYS TOUCH) in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.
Read the detailed description
The study will comprise a prospective, open-labeled, multi-center study to assess the clinical efficacy, functionality and device performance of the new portable negative pressure wound therapy system in the management of acute, sub-acute and chronic wounds.
The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to ensure minimum numbers in each group for analysis.
The primary objective of the study is to determine the time (days) to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention.
- Conditions
- Wound and Injuries, Surgical Wound Dehiscence
- Being tested
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Keywords
- Negative Pressure Wound Therapy
- Medical subject headings
- Wounds and Injuries, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENASYS TOUCH Negative Pressure Wound Therapy SystemDevice
Also called "RENASYS TOUCH NPWT" System
RENASYS TOUCH NPWT System was administered to all participants.
| Study group | Role | What they receive |
|---|---|---|
| RENASYS TOUCH Negative Pressure Wound Therapy Device | Experimental | Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the intermittent/variable therapy mode, for up to 28 days of therapy. Receives: Device: RENASYS TOUCH Negative Pressure Wound Therapy System |
| RENASYS TOUCH Negative Pressure Wound Therapy System | Active comparator | Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the continuous therapy mode for up to 28 days of therapy. Receives: Device: RENASYS TOUCH Negative Pressure Wound Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Measured: 28 days
Secondary outcomes (9)
To determine the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Measured: 28 days
To assess the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention, in wounds that are randomized to intermittent or continuous therapy mode
Measured: 28 days
The percentage change in wound area
To assess progress towards wound closure using the percentage change in wound area (cm2)
Measured: 28 days
The number of patients with a confirmed clinical infection or presenting with clinical signs of infection
Patients that have a confirmed clinical infection or the number of patients that present with clinical signs of infection in their reference wound
Measured: 28 days
The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other
To assess the condition of the patients surrounding skin
Measured: 28 days
To record the patients level of pain using a 10-point pain scale, on application and during therapy, in patient's wounds that are randomised to intermittent or continuous therapy mode
To assess the patients level of pain on application and during therapy
Measured: 28 days
The study will monitor safety in use and will record and assess all adverse events that occur during the study
Measured: 28 days
The percentage change in wound volume
To assess progress towards wound closure using the percentage change in wound area (cm3)
Measured: 28 days
The percentage change in wound depth
To assess progress towards wound closure using the percentage change in wound depth (mm)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Wound and InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Forlee, MD, Principal investigator, Dr Matley & Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565043
- Sponsor's protocol ID
- CT13/01
- Acronym
- NPWT
- Status last verified
- Feb 2018
- First submitted
- 28 Sep 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
PubMed 9188970Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
PubMed 9188971Krug E, Berg L, Lee C, Hudson D, Birke-Sorensen H, Depoorter M, Dunn R, Jeffery S, Duteille F, Bruhin A, Caravaggi C, Chariker M, Dowsett C, Ferreira F, Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Malmsjo M, Rome P, Vig S, Runkel N, Martin R, Smith J; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011 Feb;42 Suppl 1:S1-12. doi: 10.1016/S0020-1383(11)00041-6.
PubMed 21316515Birke-Sorensen H, Malmsjo M, Rome P, Hudson D, Krug E, Berg L, Bruhin A, Caravaggi C, Chariker M, Depoorter M, Dowsett C, Dunn R, Duteille F, Ferreira F, Francos Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Jeffery S, Lee C, Vig S, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011 Sep;64 Suppl:S1-16. doi: 10.1016/j.bjps.2011.06.001. Epub 2011 Aug 24.
PubMed 21868296Vig S, Dowsett C, Berg L, Caravaggi C, Rome P, Birke-Sorensen H, Bruhin A, Chariker M, Depoorter M, Dunn R, Duteille F, Ferreira F, Martinez JM, Grudzien G, Hudson D, Ichioka S, Ingemansson R, Jeffery S, Krug E, Lee C, Malmsjo M, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. 2011 Dec;20 Suppl 1:S1-18. doi: 10.1016/j.jtv.2011.07.002. Epub 2011 Nov 25.
PubMed 22119531Hudson DA, Adams KG, Van Huyssteen A, Martin R, Huddleston EM. Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system. Int Wound J. 2015 Apr;12(2):195-201. doi: 10.1111/iwj.12080. Epub 2013 May 7.
PubMed 23647737Clare MP, Fitzgibbons TC, McMullen ST, Stice RC, Hayes DF, Henkel L. Experience with the vacuum assisted closure negative pressure technique in the treatment of non-healing diabetic and dysvascular wounds. Foot Ankle Int. 2002 Oct;23(10):896-901. doi: 10.1177/107110070202301002.
PubMed 12398140Mendonca DA, Cosker T, Makwana NK. Vacuum-assisted closure to aid wound healing in foot and ankle surgery. Foot Ankle Int. 2005 Sep;26(9):761-6. doi: 10.1177/107110070502600915.
PubMed 16174508McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM, Farinas LP. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy Wound Manage. 2000 Aug;46(8):28-32, 34.
PubMed 11189545
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multi-centre Study to Evaluate Clinical Efficacy, Functionality and Device Performance of a New Portable Negative Pressure Wound Therapy System (RENASYS TOUCH) in the Management of Acute, Sub-acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT02565043
- Acronym / sponsor ID
- NPWT / CT13/01
- Conditions
- Wound and Injuries, Surgical Wound Dehiscence
- Keywords
- Negative Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Oct 2015 (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 study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.
Detailed description
The study will comprise a prospective, open-labeled, multi-center study to assess the clinical efficacy, functionality and device performance of the new portable negative pressure wound therapy system in the management of acute, sub-acute and chronic wounds.
The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to ensure minimum numbers in each group for analysis.
The primary objective of the study is to determine the time (days) to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RENASYS TOUCH Negative Pressure Wound Therapy Device | Experimental | Device: RENASYS TOUCH Negative Pressure Wound Therapy SystemActive Device: "RENASYS TOUCH NPWT" device administered to all patients using the intermittent/variable therapy mode, for up to 28 days of therapy. |
| RENASYS TOUCH Negative Pressure Wound Therapy System | Active comparator | Device: RENASYS TOUCH Negative Pressure Wound Therapy SystemActive Device: "RENASYS TOUCH NPWT" device administered to all patients using the continuous therapy mode for up to 28 days of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is able to understand the study and is willing to consent to the study
- The patient consents to the on-going use of their de-identified photos by the Sponsor for purposes outside of this study
- Patients must be at least 18 years old
- Males and females. If female, they must not be pregnant. If female and of reproductive age, a pregnancy test will be provided
- Patient must have an acute, sub-acute or chronic wound that would benefit from the application of topical Negative Pressure Wound Therapy (NPWT)
Key exclusion criteria (16 listed)
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this study previously and who [healed or] were withdrawn.
- Patients who are unable to understand the aims and objectives of the study.
- Presence of necrotic tissue, or >25% slough in the reference wound bed. Once debridement has taken place, treatment with the investigational product may proceed
- Patients whose reference wound displays evidence of extensive tunnelling or sinus tracts
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 |
|---|---|---|
| RENASYS TOUCH Negative Pressure Wound Therapy SystemAlso: "RENASYS TOUCH NPWT" SystemRENASYS TOUCH NPWT System was administered to all participants. | Device | RENASYS TOUCH Negative Pressure Wound Therapy Device, RENASYS TOUCH Negative Pressure Wound Therapy System |
Primary outcome
The time to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time frame: 28 days
9 secondary outcomes
To determine the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time frame: 28 days
To assess the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention, in wounds that are randomized to intermittent or continuous therapy mode
Time frame: 28 days
The percentage change in wound area
Time frame: 28 days
The number of patients with a confirmed clinical infection or presenting with clinical signs of infection
Time frame: 28 days
The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other
Time frame: 28 days
To record the patients level of pain using a 10-point pain scale, on application and during therapy, in patient's wounds that are randomised to intermittent or continuous therapy mode
Time frame: 28 days
The study will monitor safety in use and will record and assess all adverse events that occur during the study
Time frame: 28 days
The percentage change in wound volume
Time frame: 28 days
The percentage change in wound depth
Time frame: 28 days
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 Feb 2018.
- Background: PubMed 9188970Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
- Background: PubMed 9188971Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
- Background: PubMed 21316515Krug E, Berg L, Lee C, Hudson D, Birke-Sorensen H, Depoorter M, Dunn R, Jeffery S, Duteille F, Bruhin A, Caravaggi C, Chariker M, Dowsett C, Ferreira F, Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Malmsjo M, Rome P, Vig S, Runkel N, Martin R, Smith J; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011 Feb;42 Suppl 1:S1-12. doi: 10.1016/S0020-1383(11)00041-6.
- Background: PubMed 21868296Birke-Sorensen H, Malmsjo M, Rome P, Hudson D, Krug E, Berg L, Bruhin A, Caravaggi C, Chariker M, Depoorter M, Dowsett C, Dunn R, Duteille F, Ferreira F, Francos Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Jeffery S, Lee C, Vig S, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011 Sep;64 Suppl:S1-16. doi: 10.1016/j.bjps.2011.06.001. Epub 2011 Aug 24.
- Background: PubMed 22119531Vig S, Dowsett C, Berg L, Caravaggi C, Rome P, Birke-Sorensen H, Bruhin A, Chariker M, Depoorter M, Dunn R, Duteille F, Ferreira F, Martinez JM, Grudzien G, Hudson D, Ichioka S, Ingemansson R, Jeffery S, Krug E, Lee C, Malmsjo M, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. 2011 Dec;20 Suppl 1:S1-18. doi: 10.1016/j.jtv.2011.07.002. Epub 2011 Nov 25.
- Background: PubMed 23647737Hudson DA, Adams KG, Van Huyssteen A, Martin R, Huddleston EM. Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system. Int Wound J. 2015 Apr;12(2):195-201. doi: 10.1111/iwj.12080. Epub 2013 May 7.
- Background: PubMed 12398140Clare MP, Fitzgibbons TC, McMullen ST, Stice RC, Hayes DF, Henkel L. Experience with the vacuum assisted closure negative pressure technique in the treatment of non-healing diabetic and dysvascular wounds. Foot Ankle Int. 2002 Oct;23(10):896-901. doi: 10.1177/107110070202301002.
- Background: PubMed 16174508Mendonca DA, Cosker T, Makwana NK. Vacuum-assisted closure to aid wound healing in foot and ankle surgery. Foot Ankle Int. 2005 Sep;26(9):761-6. doi: 10.1177/107110070502600915.
- Background: PubMed 11189545McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM, Farinas LP. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy Wound Manage. 2000 Aug;46(8):28-32, 34.
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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.
Martin Forlee, MD principal investigator
Dr Matley & Partners
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENASYS TOUCH Negative Pressure Wound Therapy System in people with Wound and Injuries and Surgical Wound Dehiscence, run by Smith & Nephew, Inc. at 2 sites in South Africa.
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 7 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. 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 time to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention (time frame: 28 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 NCT02565043, which also lists 9 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 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.