HyperhidrosisT3-T4RYNCT04721483
T3-T4 Gray Sympathycotomy Versus Ramicotomy for Hyperhidrosis
A study testing Ramicotomy in people with Hyperhidrosis and Compensatory Sweating, run by University of Valencia at 2 sites in Spain.
Trial summary
It is presented a further refinement in palmar hyperhidrosis's surgical treatment to improve results and reduce side effects, mainly compensatory hyperhidrosis. It seems that a more selective sympathetic system lesion, namely a selective T3 and T4 gray rami communicantes lesion, allows retaining some residual sweating… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperhidrosis, Compensatory Sweating, Compensatory Hyperhidrosis
- What is being tested?
- Ramicotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2016to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- palmar HH with or without axillary HH refractive to conservative treatments
- or reluctant to continue with them after six months and willing to undergo surgical treatment,
- Hyperhidrosis Disease Severity Score grade D
Who cannot join
- previous thoracic pathology (lung infections, particularly pulmonary empyema, pneumothorax, hemothorax, rib fractures, neoplasms)
- heart failure
- hypothyroidism
- tuberculosis
- bradycardia (40 pulsations/min)
- alcoholism
Show all 14Show fewer
- drug addiction
- BMI >30
- pregnancy
- generalized HH or related to any health disorder
- comorbidities
- or medication intake that induces excessive sweating
- patients with primary facial or plantar HH
- patients not complying with follow-ups
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital General Universitario de Valencia
Valencia, 46014
Vicente Vanaclocha
Valencia, 46015
About this study
Official title: Selective T3-T4 Sympathicotomy Versus Gray Ramicotomy on Outcome and Quality of Life in Hyperhidrosis Patients. A Randomized Clinical Trial
It is presented a further refinement in palmar hyperhidrosis's surgical treatment to improve results and reduce side effects, mainly compensatory hyperhidrosis. It seems that a more selective sympathetic system lesion, namely a selective T3 and T4 gray rami communicantes lesion, allows retaining some residual sweating in the hands without inducing compensatory sweating in the abdomen, thighs, and feet. The result is greater patient satisfaction. There has been a long journey since Wittmosser et al. suggested the technique of gray and white ramicotomy in 1992. In this way, the attending physicians have refined the surgical procedure progressively. The two last research groups reporting their results with selective gray ramicotomy (the idea now is not to lesion the white rami communicantes) entailed extensive lesions (T2 to T4/T5). This study shows that a more selective T3 and T4 selective gray ramicotomy achieves excellent results with fewer side effects. Thus, it is a further step toward improving outcomes, reducing side effects, and increasing patients' satisfaction.
Additionally, the present work has concentrated on objective ways to measure compensatory hyperhidrosis by measuring the sweat production in milliliters of water and the temperature changes in degrees Celsius. This accurate measurement removes the subjectivity induced when we base the results on the treating physicians' opinions or the patients themselves.
The objective measurement of the sweat production in milliliters of water and temperature rise in degrees Celsius has allowed the research group to reach conclusions independent of opinions both from treating physicians and patients themselves. Also, a more selective gray rami communicantes lesion can achieve better results with less compensatory hyperhidrosis and with better patient's satisfaction
Read the detailed description
Ever since the introduction of thoracic sympathectomy in the treatment of palmar and axillary hyperhidrosis, there has been a continuous quest to find a way to reduce its most unpleasant side effect: compensatory hyperhidrosis (CH). Following the idea of minimizing the surgically induced damage to the sympathetic chain, Wittmoser introduced in 1992, the ramicotomy technique. It entailed the selective lesion of the rami communicantes, both white and gray, from T2 to T4-T5. This surgical technique was not as selective as expected because it damaged the sympathetic input for the lungs and heart, and the head and face. Wittmoser described this surgical technique but never published any results. Gossot4 in 1997 compared this technique with the sympathectomy of the same ganglia in 54 patients. He found that CH's incidence was the same in both groups, but the severity was less in the ramicotomy than in the sympathectomy group. The recurrence rate was more prominent in the first than in the second group (5% ramicotomy versus 0% sympathectomy). Other researchers have confirmed these results.
More studies compared the sympathectomy with the ramicotomy in the following years, confirming that ramicotomy has a lower incidence of CH5-10, with less dry hands but with some recurrences.
In a step forward, Coveliers et al.11 lesioned only the T2 T3 and T4 gray rami communicantes, not touching the sympathetic chain or the white rami communicantes, with CH dropping to 7.2% and no recurrences. Akil et al.12 reported the lesion of the T2-T5 gray rami communicantes with no CH and again with no recurrences. Both studies entail a more extensive lesion, including T2, and one of those studies, T5. There is an agreement to avoid lesioning T2 in many previous reports to reduce the incidence and severity of CH.
- Being tested
- Ramicotomy
- Keywords
- Hyperhidrosis, Ramicotomy, Sympathectomy, Sympathicotomy, Compensatory hyperhidrosis, Gustatory sweating
- Medical subject headings
- Hyperhidrosis, Sweating, Gustatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamicotomyProcedure or surgery
We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia
| Study group | Role | What they receive |
|---|---|---|
| T3-T4 sympathicotomy | Active comparator | In this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis Receives: Procedure: Ramicotomy |
| T3-T4 ramicotomy | Experimental | In this group, patients underwent a selective T3 and T4 gray ramicotomy Receives: Procedure: Ramicotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compensatory sweating
We will measure the increase in sweating in the chest, abdomen thighs and feet by capturing the sweat produced in these body areas in a period of 15 minutes in a closed room at 25ºC and 85% humidity. The sweat will be captured with a special cellulose pad and these pads will be weighted with a precision scale before and after being placed in the body areas to be analysed. The sweat production will be known by the milliliters of water captured in the pads used to capture it
Measured: 1 year
Postoperative quality of life
We will compare with a questionnaire that patients will fulfill baseline and in every follow-up visit on the quality of life. It will be used the quality of life questionnaire developed by Amir M, Arish A, Weinstein Y, Pfeffer M, Levy Y. Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results. Isr J Psychiatry Relat Sci. 2000;37(1):25-31.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Apr 2016
- Primary completion1 Oct 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups. One with T3-T4 sympathicotomy and another with T3-T4 gray ramicotomy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721483
- Sponsor's protocol ID
- CEIm 24-02-2016
- Acronym
- T3-T4RY
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gossot D, Toledo L, Fritsch S, Celerier M. Thoracoscopic sympathectomy for upper limb hyperhidrosis: looking for the right operation. Ann Thorac Surg. 1997 Oct;64(4):975-8. doi: 10.1016/s0003-4975(97)00799-6.
PubMed 9354512Cho HM, Chung KY, Kim DJ, Lee KJ, Kim KD. The comparison of VATS ramicotomy and VATS sympathicotomy for treating essential hyperhidrosis. Yonsei Med J. 2003 Dec 30;44(6):1008-13. doi: 10.3349/ymj.2003.44.6.1008.
PubMed 14703609Lee DY, Kim DH, Paik HC. Selective division of T3 rami communicantes (T3 ramicotomy) in the treatment of palmar hyperhidrosis. Ann Thorac Surg. 2004 Sep;78(3):1052-5. doi: 10.1016/j.athoracsur.2004.03.034.
PubMed 15337046Cheng YJ, Wu HH, Kao EL. Video-assisted thoracoscopic sympathetic ramicotomy for hyperhidrosis--a way to reduce the complications. Ann Chir Gynaecol. 2001;90(3):172-4.
PubMed 11695787Lee DY, Paik HC, Kim DH, Kim HW. Comparative analysis of T3 selective division of rami communicantes (ramicotomy) to T3 sympathetic clipping in treatment of palmar hyperhidrosis. Clin Auton Res. 2003 Dec;13 Suppl 1:I45-7. doi: 10.1007/s10286-003-1115-1.
PubMed 14673673Kim DY, Paik HC, Lee DY. Comparative analysis of T2 selective division of rami-communicantes (ramicotomy) with T2 sympathetic clipping in the treatment of craniofacial hyperhidrosis. Eur J Cardiothorac Surg. 2004 Aug;26(2):396-400. doi: 10.1016/j.ejcts.2004.04.030.
PubMed 15296904Hwang JJ, Kim DH, Hong YJ, Lee DY. A comparison between two types of limited sympathetic surgery for palmar hyperhidrosis. Surg Today. 2013 Apr;43(4):397-402. doi: 10.1007/s00595-012-0246-1. Epub 2012 Jul 15.
PubMed 22798011Coveliers H, Meyer M, Gharagozloo F, Wisselink W, Rauwerda J, Margolis M, Tempesta B, Strother E. Robotic selective postganglionic thoracic sympathectomy for the treatment of hyperhidrosis. Ann Thorac Surg. 2013 Jan;95(1):269-74. doi: 10.1016/j.athoracsur.2012.08.013. Epub 2012 Nov 14.
PubMed 23158099Akil A, Semik M, Fischer S. Efficacy of Miniuniportal Video-Assisted Thoracoscopic Selective Sympathectomy (Ramicotomy) for the Treatment of Severe Palmar and Axillar Hyperhidrosis. Thorac Cardiovasc Surg. 2019 Aug;67(5):415-419. doi: 10.1055/s-0038-1642030. Epub 2018 May 8.
PubMed 29739022Zhang W, Yu D, Wei Y, Xu J, Zhang X. A systematic review and meta-analysis of T2, T3 or T4, to evaluate the best denervation level for palmar hyperhidrosis. Sci Rep. 2017 Mar 9;7(1):129. doi: 10.1038/s41598-017-00169-w.
PubMed 28273934Cai SW, Shen N, Li DX, Wei B, An J, Zhang JH. Compensatory sweating after restricting or lowering the level of sympathectomy: a systematic review and meta-analysis. Clinics (Sao Paulo). 2015 Mar;70(3):214-9. doi: 10.6061/clinics/2015(03)11. Epub 2015 Mar 1.
PubMed 26017654Scognamillo F, Serventi F, Attene F, Torre C, Paliogiannis P, Pala C, Trignano E, Trignano M. T2-T4 sympathectomy versus T3-T4 sympathicotomy for palmar and axillary hyperhidrosis. Clin Auton Res. 2011 Apr;21(2):97-102. doi: 10.1007/s10286-010-0110-6. Epub 2011 Jan 19.
PubMed 21243401Dogru MV, Sezen CB, Girgin O, Cansever L, Kocaturk CI, Metin M, Dincer SI. Is there any relationship between quality of life and the level of sympathectomy in primary palmar hyperhidrosis? Single-center experience. Gen Thorac Cardiovasc Surg. 2020 Mar;68(3):273-279. doi: 10.1007/s11748-019-01210-7. Epub 2019 Sep 21.
PubMed 31542862Weksler B, Blaine G, Souza ZB, Gavina R. Transection of more than one sympathetic chain ganglion for hyperhidrosis increases the severity of compensatory hyperhidrosis and decreases patient satisfaction. J Surg Res. 2009 Sep;156(1):110-5. doi: 10.1016/j.jss.2009.04.015. Epub 2009 May 14.
PubMed 19631343Yazbek G, Wolosker N, de Campos JR, Kauffman P, Ishy A, Puech-Leao P. Palmar hyperhidrosis--which is the best level of denervation using video-assisted thoracoscopic sympathectomy: T2 or T3 ganglion? J Vasc Surg. 2005 Aug;42(2):281-5. doi: 10.1016/j.jvs.2005.03.041.
PubMed 16102627
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective T3-T4 Sympathicotomy Versus Gray Ramicotomy on Outcome and Quality of Life in Hyperhidrosis Patients. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04721483
- Acronym / sponsor ID
- T3-T4RY / CEIm 24-02-2016
- Keywords
- Hyperhidrosis, Ramicotomy, Sympathectomy, Sympathicotomy, Compensatory hyperhidrosis, Gustatory sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 22 Jan 2021 (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 presented a further refinement in palmar hyperhidrosis's surgical treatment to improve results and reduce side effects, mainly compensatory hyperhidrosis. It seems that a more selective sympathetic system lesion, namely a selective T3 and T4 gray rami communicantes lesion, allows retaining some residual sweating in the hands without inducing compensatory sweating in the abdomen, thighs, and feet. The result is greater patient satisfaction. There has been a long journey since Wittmosser et al. suggested the technique of gray and white ramicotomy in 1992. In this way, the attending physicians have refined the surgical procedure progressively. The two last research groups reporting their results with selective gray ramicotomy (the idea now is not to lesion the white rami communicantes) entailed extensive lesions (T2 to T4/T5). This study shows that a more selective T3 and T4 selective gray ramicotomy achieves excellent results with fewer side effects. Thus, it is a further step toward improving outcomes, reducing side effects, and increasing patients' satisfaction.
Additionally, the present work has concentrated on objective ways to measure compensatory hyperhidrosis by measuring the sweat production in milliliters of water and the temperature changes in degrees Celsius. This accurate measurement removes the subjectivity induced when we base the results on the treating physicians' opinions or the patients themselves.
The objective measurement of the sweat production in milliliters of water and temperature rise in degrees Celsius has allowed the research group to reach conclusions independent of opinions both from treating physicians and patients themselves. Also, a more selective gray rami communicantes lesion can achieve better results with less compensatory hyperhidrosis and with better patient's satisfaction
Detailed description
Ever since the introduction of thoracic sympathectomy in the treatment of palmar and axillary hyperhidrosis, there has been a continuous quest to find a way to reduce its most unpleasant side effect: compensatory hyperhidrosis (CH). Following the idea of minimizing the surgically induced damage to the sympathetic chain, Wittmoser introduced in 1992, the ramicotomy technique. It entailed the selective lesion of the rami communicantes, both white and gray, from T2 to T4-T5. This surgical technique was not as selective as expected because it damaged the sympathetic input for the lungs and heart, and the head and face. Wittmoser described this surgical technique but never published any results. Gossot4 in 1997 compared this technique with the sympathectomy of the same ganglia in 54 patients. He found that CH's incidence was the same in both groups, but the severity was less in the ramicotomy than in the sympathectomy group. The recurrence rate was more prominent in the first than in the second group (5% ramicotomy versus 0% sympathectomy). Other researchers have confirmed these results.
More studies compared the sympathectomy with the ramicotomy in the following years, confirming that ramicotomy has a lower incidence of CH5-10, with less dry hands but with some recurrences.
In a step forward, Coveliers et al.11 lesioned only the T2 T3 and T4 gray rami communicantes, not touching the sympathetic chain or the white rami communicantes, with CH dropping to 7.2% and no recurrences. Akil et al.12 reported the lesion of the T2-T5 gray rami communicantes with no CH and again with no recurrences. Both studies entail a more extensive lesion, including T2, and one of those studies, T5. There is an agreement to avoid lesioning T2 in many previous reports to reduce the incidence and severity of CH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups. One with T3-T4 sympathicotomy and another with T3-T4 gray ramicotomy
| Arm | Type | Receives |
|---|---|---|
| T3-T4 sympathicotomy | Active comparator | Procedure: RamicotomyIn this group, patients underwent a classical T3 and T4 sympathicotomy to treat primary palmar hyperhidrosis |
| T3-T4 ramicotomy | Experimental | Procedure: RamicotomyIn this group, patients underwent a selective T3 and T4 gray ramicotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- palmar HH with or without axillary HH refractive to conservative treatments
- or reluctant to continue with them after six months and willing to undergo surgical treatment,
- Hyperhidrosis Disease Severity Score grade D
Key exclusion criteria (14 listed)
- previous thoracic pathology (lung infections, particularly pulmonary empyema, pneumothorax, hemothorax, rib fractures, neoplasms)
- heart failure
- hypothyroidism
- tuberculosis
- bradycardia (40 pulsations/min)
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 |
|---|---|---|
| RamicotomyWe will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia | Procedure or surgery | T3-T4 ramicotomy, T3-T4 sympathicotomy |
Primary outcome
Compensatory sweating
Time frame: 1 year
We will measure the increase in sweating in the chest, abdomen thighs and feet by capturing the sweat produced in these body areas in a period of 15 minutes in a closed room at 25ºC and 85% humidity. The sweat will be captured with a special cellulose pad and these pads will be weighted with a precision scale before and after being placed in the body areas to be analysed. The sweat production will be known by the milliliters of water captured in the pads used to capture it
Postoperative quality of life
Time frame: 1 year
We will compare with a questionnaire that patients will fulfill baseline and in every follow-up visit on the quality of life. It will be used the quality of life questionnaire developed by Amir M, Arish A, Weinstein Y, Pfeffer M, Levy Y. Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results. Isr J Psychiatry Relat Sci. 2000;37(1):25-31.
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 22 Jan 2021.
- Background: PubMed 9354512Gossot D, Toledo L, Fritsch S, Celerier M. Thoracoscopic sympathectomy for upper limb hyperhidrosis: looking for the right operation. Ann Thorac Surg. 1997 Oct;64(4):975-8. doi: 10.1016/s0003-4975(97)00799-6.
- Background: PubMed 14703609Cho HM, Chung KY, Kim DJ, Lee KJ, Kim KD. The comparison of VATS ramicotomy and VATS sympathicotomy for treating essential hyperhidrosis. Yonsei Med J. 2003 Dec 30;44(6):1008-13. doi: 10.3349/ymj.2003.44.6.1008.
- Background: PubMed 15337046Lee DY, Kim DH, Paik HC. Selective division of T3 rami communicantes (T3 ramicotomy) in the treatment of palmar hyperhidrosis. Ann Thorac Surg. 2004 Sep;78(3):1052-5. doi: 10.1016/j.athoracsur.2004.03.034.
- Background: PubMed 11695787Cheng YJ, Wu HH, Kao EL. Video-assisted thoracoscopic sympathetic ramicotomy for hyperhidrosis--a way to reduce the complications. Ann Chir Gynaecol. 2001;90(3):172-4.
- Background: PubMed 14673673Lee DY, Paik HC, Kim DH, Kim HW. Comparative analysis of T3 selective division of rami communicantes (ramicotomy) to T3 sympathetic clipping in treatment of palmar hyperhidrosis. Clin Auton Res. 2003 Dec;13 Suppl 1:I45-7. doi: 10.1007/s10286-003-1115-1.
- Background: PubMed 15296904Kim DY, Paik HC, Lee DY. Comparative analysis of T2 selective division of rami-communicantes (ramicotomy) with T2 sympathetic clipping in the treatment of craniofacial hyperhidrosis. Eur J Cardiothorac Surg. 2004 Aug;26(2):396-400. doi: 10.1016/j.ejcts.2004.04.030.
- Background: PubMed 22798011Hwang JJ, Kim DH, Hong YJ, Lee DY. A comparison between two types of limited sympathetic surgery for palmar hyperhidrosis. Surg Today. 2013 Apr;43(4):397-402. doi: 10.1007/s00595-012-0246-1. Epub 2012 Jul 15.
- Background: PubMed 23158099Coveliers H, Meyer M, Gharagozloo F, Wisselink W, Rauwerda J, Margolis M, Tempesta B, Strother E. Robotic selective postganglionic thoracic sympathectomy for the treatment of hyperhidrosis. Ann Thorac Surg. 2013 Jan;95(1):269-74. doi: 10.1016/j.athoracsur.2012.08.013. Epub 2012 Nov 14.
- Background: PubMed 29739022Akil A, Semik M, Fischer S. Efficacy of Miniuniportal Video-Assisted Thoracoscopic Selective Sympathectomy (Ramicotomy) for the Treatment of Severe Palmar and Axillar Hyperhidrosis. Thorac Cardiovasc Surg. 2019 Aug;67(5):415-419. doi: 10.1055/s-0038-1642030. Epub 2018 May 8.
- Background: PubMed 28273934Zhang W, Yu D, Wei Y, Xu J, Zhang X. A systematic review and meta-analysis of T2, T3 or T4, to evaluate the best denervation level for palmar hyperhidrosis. Sci Rep. 2017 Mar 9;7(1):129. doi: 10.1038/s41598-017-00169-w.
- Background: PubMed 26017654Cai SW, Shen N, Li DX, Wei B, An J, Zhang JH. Compensatory sweating after restricting or lowering the level of sympathectomy: a systematic review and meta-analysis. Clinics (Sao Paulo). 2015 Mar;70(3):214-9. doi: 10.6061/clinics/2015(03)11. Epub 2015 Mar 1.
- Background: PubMed 21243401Scognamillo F, Serventi F, Attene F, Torre C, Paliogiannis P, Pala C, Trignano E, Trignano M. T2-T4 sympathectomy versus T3-T4 sympathicotomy for palmar and axillary hyperhidrosis. Clin Auton Res. 2011 Apr;21(2):97-102. doi: 10.1007/s10286-010-0110-6. Epub 2011 Jan 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramicotomy in people with Hyperhidrosis and Compensatory Sweating, run by University of Valencia at 2 sites in Spain.
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 3 inclusion and 14 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 22 Jan 2021. 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 Spain. 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?
Compensatory sweating (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT04721483, 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 22 Jan 2021.