Diagnosis Exclusion of Recurrent Deep Vein Thrombosis of the Lower Limbs (ULTREC)

Safety of a Management Strategy Based on Colour Doppler ULTrasound and D-Dimer Testing for the Diagnosis Exclusion of RECurrent Deep Vein Thrombosis of the Lower Limbs. The ULTREC Project

The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs.

DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement.

Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity.

The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment.

All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Diagnostic test: Colour doppler ultrasound with or without D-dimer test

Detailed Description

Venous thromboembolism (VTE) recurrence is a common situation after stopping anticoagulant treatment. This recurrence requires extended anticoagulant therapy to prevent thrombosis progression and embolization, but given an increased bleeding risk with prolonged treatment, an accurate diagnosis for VTE recurrence is needed.

Unfortunately, there is no reference standard for the diagnosis of deep vein thrombosis (DVT) recurrence and objective and accurate diagnostic methods are lacking. Clinical assessment does not allow discriminating between a previous and a recent thrombosis and there is no clinical prediction rule specific to the suspicion of DVT recurrence. D-dimer assays alone may not be able to safely exclude the diagnosis of DVT recurrence, and they have not been sufficiently validated in combination with clinical probability. The same holds for imaging modalities because normalisation rate after proximal DVT is low and a "residual thrombosis" may make difficult the diagnosis of a new thrombosis episode at the same site. Phlebography is non-diagnostic in 33% of cases. CT-venography has never been evaluated and MRI direct thrombus imaging (MRDTI) although very promising is still under evaluation.

As compression ultrasound (CUS) may be equivocal due to a residual thrombosis, a comparison to baseline measurements of residual vein diameter after full compression at the common femoral and the popliteal vein segments in cross-sectional plane has been suggested with an increase in diameter superior to 2 or 4 mm as a diagnosis criterion. This method has many major limitations related to: 1/the need for a previous measurement almost never available in practice, 2/ the potential for recurrence at a different site than that previously measured, 3/ a poor inter-observer agreement or at least inconsistent inter-observer variability between studies, 4/ small sample sizes in diagnostic accuracy and in diagnostic management studies and 5/ lack of external validation. Due to these limitations, recurrent ipsilateral DVT is mainly diagnosed by CUS when it occurs in a new or a normalised vein segment.

Colour Doppler ultrasound (CDUS) enables to study both the thrombus and the blood flow characteristics that might help to overcome the limitations of CUS and diameter measurements. Although CDUS has never been assessed for DVT recurrence in a study, it is used in every day clinical practice and seems very helpful. The diagnosis may be easily established using the same CDUS criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely exclude the diagnosis of recurrent DVT while maintaining a good specificity.

The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal (non-diagnostic) CDUS, a D-Dimer test is performed followed by repeat CDUS on D7±2 if D-dimer test result is abnormal. Meanwhile, patients are not treated by anticoagulants. A negative D-dimer test or an unchanged CDUS on D7±2 qualifies patients as free from a new DVT. Conversely a change in CDUS qualifies patients as having a new DVT. Only patients with a new DVT are treated. All patients have a 3-month follow-up for the assessment of venous thromboembolic and bleeding events by an independent adjudication committee.

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa JOBIC; Phone Number: +33 04 83 77 20 61; Email: asmaa.jobic@ch-toulon.fr

Study Locations

• France
  • Paris, France, 75674
    • Hôpital Saint Joseph
  • Allier
    • Vichy, Allier, France, 03200
      • Centre Hospitalier de Vichy
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • Centre Hospitalier Universitaire de Nice
  • Aude
    • Carcassonne, Aude, France, 1060
      • Centre Hospitalier de Carcassonne
    • Carcassonne, Aude, France, 11000
      • Centre d'angiologie
  • Bouches Du Rhône
    • Marseille, Bouches Du Rhône, France, 13385
      • APHM La Timone
  • Bouches-du-Rhône
    • Aubagne, Bouches-du-Rhône, France, 13400
      • Cabinet libéral Pung
    • Istres, Bouches-du-Rhône, France, 13800
      • Cabinet libéral Dias
    • Marseille, Bouches-du-Rhône, France, 13003
      • Cabinet libéral Sidoli
    • Marseille, Bouches-du-Rhône, France, 13011
      • Cabinet libéral El Haddad
  • Corse Du Sud
    • Ajaccio, Corse Du Sud, France, 20090
      • Cabinet libéral De Mari
    • Ajaccio, Corse Du Sud, France, 20090
      • Cabinet libéral Secondi
  • Cote d'Or
    • Dijon, Cote d'Or, France, 21079
      • Centre Hospitalier Universitaire Bocage
  • Côte d'Or
    • Dijon, Côte d'Or, France, 21079
      • Centre Hospitalier Universitaire François Mitterrand
  • Finistère
    • Brest, Finistère, France, 29609
      • Centre hospitalier Universitaire Cavale Blanche
  • Gard
    • Nîmes, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nîmes
  • Gers
    • Auch, Gers, France, 32000
      • Centre Hospitalier d'Auch
    • Auch, Gers, France
      • Cabinet libéral Cazaux
  • Gironde
    • Bordeaux, Gironde, France, 33075
      • Hopital Saint Andre
    • Langon, Gironde, France, 33210
      • Centre de medicine vasculaire interventionnel
  • Haute Corse
    • Bastia, Haute Corse, France, 20600
      • Cabinet libéral Casanova
  • Haute-Corse
    • Bastia, Haute-Corse, France, 20200
      • Cabinet libéral Bonavita
  • Haute-Garonne
    • Balma, Haute-Garonne, France, 31130
      • Cabinet libéral Bourrinet
    • Toulouse, Haute-Garonne, France, 31059
      • Centre Hospitalier Universitaire Rangueil
    • Toulouse, Haute-Garonne, France, 31076
      • Clinique Rive Gauche
  • Hautes-Pyrénées
    • Lourdes, Hautes-Pyrénées, France, 65100
      • Cabinet libéral Wagner
    • Tarbes, Hautes-Pyrénées, France, 65000
      • Cabinet libéral Esteve
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Centre Hospitalier Universitaire de Montpellier
  • Ile-de-France
    • Paris, Ile-de-France, France, 75116
      • Centre d'explorations vasculaires
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35033
      • Centre Hospitalier Universitaire de Rennes
  • Isère
    • Grenoble, Isère, France, 38700
      • Centre Hospitalier Universitaire de Grenoble
  • Loire
    • Saint-Étienne, Loire, France, 42055
      • Centre Hospitalier Universitaire Nord
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49933
      • Centre Hospitalier Universitaire d'Angers
  • Meurthe Et Moselle
    • Nancy, Meurthe Et Moselle, France, 54511
      • Centre Hospitalier Universitaire de Nancy
  • Pas-de-Calais
    • Arras, Pas-de-Calais, France, 62000
      • Espace Artois Santé
  • Puy-de-Dôme
    • Clermont-Ferrand, Puy-de-Dôme, France, 63000
      • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Rhône
    • Lyon, Rhône, France, 69003
      • Hôpital Edouard Herriot
  • Somme
    • Amiens, Somme, France, 80054
      • Centre Hospitalier Universitaire d'Amiens
  • Var
    • Ollioules, Var, France, 83190
      • Cabinet libéral Besancon - polyclinique des Fleurs
    • Ollioules, Var, France, 83190
      • Clinique des Fleurs
    • Sanary-sur-Mer, Var, France, 83110
      • Cabinet libéral Richard
    • Six-Fours-les-Plages, Var, France, 83140
      • Cabinet libéral Ben Sedrine
    • Six-Fours-les-Plages, Var, France, 83140
      • Cabinet libéral Riviere
    • Six-Fours-les-Plages, Var, France, 83140
      • Cabinet libéral Zimmermann
    • Toulon, Var, France, 83056
      • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 18 years
• Known history of objectively documented deep vein thrombosis of the lower limb (with or without pulmonary embolism)
• Out-patients referred for clinically suspected acute recurrent ipsilateral DVT of the lower limb i.e. the occurrence of new symptoms and signs of DVT or the increase of symptoms and signs in patients with post-thrombotic syndrome
• Patients covered by social security or equivalent regimen
• Signed and dated informed consent

Exclusion Criteria:

• Known current pregnancy
• Any condition, which, in the opinion of the investigator may prevent him from performing the colour doppler ultrasound test (plaster cast, inaccessible vein segment after abdominal or pelvic surgery, or other causes that may lead to a technically inadequate CDUS)
• Delay from onset of symptoms to inclusion of more than 10 days
• Therapeutic anticoagulation for more than 48 hours in the two days prior to consent or a need for long term anticoagulation
• Prophylactic anticoagulation for more than 48 hours in the two days prior to consent
• Clinical symptoms of pulmonary embolism
• Life expectancy less than 3 months
• Patient unable to adhere to protocol or follow-up visits and contacts
• Participants under legal guardianship or incapacitation
• Patient already enrolled in a deep vein thrombosis (DVT) diagnostic research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic strategy; Colour doppler ultrasound (CDUS) with or without D-dimer test to rule-in or rule-out deep vein thrombosis recurrence	Diagnostic test: Colour doppler ultrasound with or without D-dimer test; Positive CDUS: anticoagulant treatment; Negative CDUS: no anticoagulant treatment; Non diagnostic CDUS : reference to routine D-dimer testNegative test : no anticoagulant treatmentPositive test : second CDUS 7 days (±2) after first oneNo change in CDUS : no anticoagulant treatmentChange in CDUS : anticoagulant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated symptomatic venous thromboembolic events	Rate of adjudicated symptomatic venous thromboembolic (VTE) events among patients not treated by anticoagulants according to the diagnostic strategy The criteria for recurrent VTE include: objectively confirmed pulmonary embolism (PE) by either CT pulmonary angiography or ventilation-perfusion scan,; death due to PE,; and recurrent DVT of the leg Death, cause of death, VTE comprising isolated proximal or distal DVT and PE (with or without DVT), will be adjudicated by an independent clinical event committee blinded to the classification of the diagnostic strategy.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of deep vein thrombosis recurrence	Proportion of patients with a new DVT among all patients included based on the results of the diagnostic tests used in the strategy and on the occurrence of VTE events during follow-up in patients untreated	Up to 3 months
Proportion of patients tested negative	Proportion of patients tested negative by the strategy for DVT recurrence among all patients included	A day if the diagnostic strategy is conclusive (either positive or negative) at day 0, or 7 days if it is inconclusive
Proportion of complete patients	Proportion of patients who completed the strategy	3 months
Bleeding complication occurrence	The occurrence of bleeding complications will be assessed among all patients included during a 3-month follow-up period. The severity of these complications will be adjudicated by the independent clinical event committee according to the International Society on Thrombosis and Haemostasis classification criteria.	3 months
Correlation of possible strategy failure in not anticoagulated patients and patient characteristics	Identification of clinical and ultrasound factors which could explain failure of the strategy in non anticoagulated patients	3 months
Prevalence of isolated superficial vein thrombosis	Proportion of patients with isolated superficial vein thrombosis during a 3-month follow-up among all patients included	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Centre Hospitalier Universitaire de Saint Etienne; Investigation network on venous thrombo-embolism
• Investigators: Study Director: Antoine Elias, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications and helpful links

General Publications

• Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.
• Aguilar C, del Villar V. Combined D-dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis. Am J Hematol. 2007 Jan;82(1):41-4. doi: 10.1002/ajh.20754.
• Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.
• Fraser DG, Moody AR, Morgan PS, Martel AL, Davidson I. Diagnosis of lower-limb deep venous thrombosis: a prospective blinded study of magnetic resonance direct thrombus imaging. Ann Intern Med. 2002 Jan 15;136(2):89-98. doi: 10.7326/0003-4819-136-2-200201150-00006.
• Geersing GJ, Zuithoff NP, Kearon C, Anderson DR, Ten Cate-Hoek AJ, Elf JL, Bates SM, Hoes AW, Kraaijenhagen RA, Oudega R, Schutgens RE, Stevens SM, Woller SC, Wells PS, Moons KG. Exclusion of deep vein thrombosis using the Wells rule in clinically important subgroups: individual patient data meta-analysis. BMJ. 2014 Mar 10;348:g1340. doi: 10.1136/bmj.g1340.
• Schulman S, Granqvist S, Holmstrom M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Larfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8. doi: 10.1056/NEJM199702063360601.
• Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum In: Chest. 2016 Oct;150(4):988.
• Prandoni P, Cogo A, Bernardi E, Villalta S, Polistena P, Simioni P, Noventa F, Benedetti L, Girolami A. A simple ultrasound approach for detection of recurrent proximal-vein thrombosis. Circulation. 1993 Oct;88(4 Pt 1):1730-5. doi: 10.1161/01.cir.88.4.1730.
• Goodacre S, Sampson F, Thomas S, van Beek E, Sutton A. Systematic review and meta-analysis of the diagnostic accuracy of ultrasonography for deep vein thrombosis. BMC Med Imaging. 2005 Oct 3;5:6. doi: 10.1186/1471-2342-5-6.
• Hamadah A, Alwasaidi T, LE Gal G, Carrier M, Wells PS, Scarvelis D, Gonsalves C, Forgie M, Kovacs MJ, Rodger MA. Baseline imaging after therapy for unprovoked venous thromboembolism: a randomized controlled comparison of baseline imaging for diagnosis of suspected recurrence. J Thromb Haemost. 2011 Dec;9(12):2406-10. doi: 10.1111/j.1538-7836.2011.04533.x.
• Hassen S, Barrellier MT, Seinturier C, Bosson JL, Genty C, Long A, Pernod G. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis: a rebuttal. J Thromb Haemost. 2011 Feb;9(2):414-6; author reply 417-8. doi: 10.1111/j.1538-7836.2010.04137.x. No abstract available.
• Heijboer H, Jongbloets LM, Buller HR, Lensing AW, ten Cate JW. Clinical utility of real-time compression ultrasonography for diagnostic management of patients with recurrent venous thrombosis. Acta Radiol. 1992 Jul;33(4):297-300.
• Hull RD, Carter CJ, Jay RM, Ockelford PA, Hirsch J, Turpie AG, Zielinsky A, Gent M, Powers PJ. The diagnosis of acute, recurrent, deep-vein thrombosis: a diagnostic challenge. Circulation. 1983 Apr;67(4):901-6. doi: 10.1161/01.cir.67.4.901.
• Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Perrier A, Bounameaux H. Value of D-dimer testing for the exclusion of pulmonary embolism in patients with previous venous thromboembolism. Arch Intern Med. 2006 Jan 23;166(2):176-80. doi: 10.1001/archinte.166.2.176.
• Le Gal G, Kovacs MJ, Carrier M, Do K, Kahn SR, Wells PS, Anderson DA, Chagnon I, Solymoss S, Crowther M, Righini M, Perrier A, White RH, Vickars L, Rodger M. Validation of a diagnostic approach to exclude recurrent venous thromboembolism. J Thromb Haemost. 2009 May;7(5):752-9. doi: 10.1111/j.1538-7836.2009.03324.x. Epub 2009 Feb 18.
• Linkins LA, Stretton R, Probyn L, Kearon C. Interobserver agreement on ultrasound measurements of residual vein diameter, thrombus echogenicity and Doppler venous flow in patients with previous venous thrombosis. Thromb Res. 2006;117(3):241-7. doi: 10.1016/j.thromres.2005.02.011. Epub 2005 Mar 21.
• Prandoni P, Lensing AW, Bernardi E, Villalta S, Bagatella P, Girolami A; DERECUS Investigators Group. The diagnostic value of compression ultrasonography in patients with suspected recurrent deep vein thrombosis. Thromb Haemost. 2002 Sep;88(3):402-6.
• Prandoni P, Tormene D, Dalla Valle F, Concolato A, Pesavento R. D-dimer as an adjunct to compression ultrasonography in patients with suspected recurrent deep vein thrombosis. J Thromb Haemost. 2007 May;5(5):1076-7. doi: 10.1111/j.1538-7836.2007.02455.x. Epub 2007 Mar 15. No abstract available.
• Rathbun SW, Whitsett TL, Raskob GE. Negative D-dimer result to exclude recurrent deep venous thrombosis: a management trial. Ann Intern Med. 2004 Dec 7;141(11):839-45. doi: 10.7326/0003-4819-141-11-200412070-00007.
• Tan M, Velthuis SI, Westerbeek RE, VAN Rooden CJ, VAN DER Meer FJ, Huisman MV. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis. J Thromb Haemost. 2010 Apr;8(4):848-50. doi: 10.1111/j.1538-7836.2010.03758.x. No abstract available.
• Tan M, Bornais C, Rodger M. Interobserver reliability of compression ultrasound for residual thrombosis after first unprovoked deep vein thrombosis. J Thromb Haemost. 2012 Sep;10(9):1775-82. doi: 10.1111/j.1538-7836.2012.04827.x.
• Tan M, Mol GC, van Rooden CJ, Klok FA, Westerbeek RE, Iglesias Del Sol A, van de Ree MA, de Roos A, Huisman MV. Magnetic resonance direct thrombus imaging differentiates acute recurrent ipsilateral deep vein thrombosis from residual thrombosis. Blood. 2014 Jul 24;124(4):623-7. doi: 10.1182/blood-2014-04-566380. Epub 2014 Jun 13.
• van der Hulle T, Tan M, den Exter PL, van Roosmalen MJ, van der Meer FJ, Eikenboom J, Huisman MV, Klok FA. Recurrence risk after anticoagulant treatment of limited duration for late, second venous thromboembolism. Haematologica. 2015 Feb;100(2):188-93. doi: 10.3324/haematol.2014.112896. Epub 2014 Sep 26.
• Westerbeek RE, Van Rooden CJ, Tan M, Van Gils AP, Kok S, De Bats MJ, De Roos A, Huisman MV. Magnetic resonance direct thrombus imaging of the evolution of acute deep vein thrombosis of the leg. J Thromb Haemost. 2008 Jul;6(7):1087-92. doi: 10.1111/j.1538-7836.2008.02986.x. Epub 2008 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Recurrence; Deep vein thrombosis; D-dimer; Colour doppler ultrasound; Diagnostic strategy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: 2018-CHITS-04; 2019-A00136-51 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No