TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01134536

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tapentadol (OS) Oral Solution
Description: Tapentadol OS Bodyweight \<20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight \>=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
Study: NCT04204603

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-506
Description: Tablets for oral administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-506
Description: Tablets for oral administration
Study: NCT03502824

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: PuraPly® Antimicrobial Wound Matrix
Description: PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: SOC for Pressure Ulcers
Description: SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.
Study: NCT02965482

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Wright Nebulizer
Description: Roxon Medi-Tech, Montreal, QC, Canada

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Aerogen Solo Nebulizer
Description: Aerogen Ltd., Galway, Ireland
Study: NCT01516216

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FOLFOX + bevacizumab

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FOLFOX + bevacizumab

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D
Study: NCT03598296

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Large size tube
Description: Patients in Group A are inserted the large size tube (28F).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Drainage ball
Description: Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).
Study: NCT02650752

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lapatinib in Tandem With Capecitabine
Study: NCT00439439

Intervention type: RADIATION
Group type: SHAM_COMPARATOR
Intervention: Beamer Ablation (Argon Plasma Coagulation)
Description: APC-Beamerablation of heterotopic gastric mucosa

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Beamer Ablation (Argon Plasma Coagulation)
Description: APC-Beamerablation of heterotopic gastric mucosa
Study: NCT00187551

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Interruption of enfuvirtide
Description: treatment interruption

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: enfuvirtide interrupton
Description: enfuvitide will be interrupted in patients harboring resistant virus
Study: NCT04700943

Intervention type: PROCEDURE
Intervention: Regional awake anesthesia
Description: We want to assess the impact of regional anesthesia on diaphragmatic function in patients undergoing Video-assisted thoracoscopic surgery pulmonary biopsy in interstitial lung disease
Study: NCT02471443

Intervention type: PROCEDURE
Intervention: Surgery for severe endometriosis
Description: Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
Study: NCT01126424

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Solifenacin
Description: tablet

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxybutynin
Description: capsule

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: tablet
Study: NCT00426270

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Octagam 10%
Description: Octagam 10% was supplied as a ready-to-use solution in glass bottles.
Study: NCT00047827

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Micafungin
Description: IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Liposomal Amphotericin B
Description: IV
Study: NCT04980729

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Acetabular reconstruction after tumor resection.
Description: In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Acetabular reconstruction after tumor resection.
Description: In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Acetabular reconstruction after tumor resection.
Description: In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.
Study: NCT02081209

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: The Zeltiq System
Description: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Study: NCT03595098

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Family Based Cognitive Behavioural Therapy
Description: Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Family Based Psychoeducation/Relaxation Training
Description: Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.
Study: NCT00846599

Intervention type: OTHER
Intervention: Omega-3 study meal
Description: Participant will eat a study meal high in omega-3 fatty acids.
Study: NCT04204603

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CKD-506
Description: Tablets for oral administration
Study: NCT00846599

Intervention type: OTHER
Intervention: Saturated fat study meal
Description: Participant will eat a study meal high in saturated fat.
Study: NCT01283347

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 18F-DTBZ
Description: During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG
Study: NCT01117870

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pulsed Radiofrequency
Description: 120 seconds at 42 degrees celsius

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.
Study: NCT01040819

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pioglitazone
Description: Patients will receive PIO 15 mg/d for one month, then 55 patients continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. Other non-diabetes drugs should not be changed. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin \>162 mg/d, steroids and prostaglandin analogs will be prohibited.
Study: NCT04204603

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Tablets for oral administration
Study: NCT04055532

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
Study: NCT05080985

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: TPVB
Description: 20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ESPB
Description: 20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacain
Description: 20 ml 0.375 % bupivacaine was injected

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bupivacain
Description: 20 ml 0.375 % bupivacaine was injected
Study: NCT03073707

Intervention type: BEHAVIORAL
Intervention: Sample collection
Description: Stool samples will be collected from household members of children diagnosed with NTS infection. In addition stool samples of animals and rats will be collected as well as samples of the water supply of the household.
Study: NCT01951300

Intervention type: OTHER
Group type: OTHER
Intervention: Gallium-68 citrate
Description: Single intravenous bolus injection of 200 MBq of Gallium-68 citrate radiopharmaceutical
Study: NCT01592955

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: EYEOP1
Description: Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
Study: NCT01260909

Intervention type: DEVICE
Intervention: Real-time kV/MV Prostate Imaging
Description: The kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC).
Study: NCT02690727

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RP6530
Description: Single oral dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RP6530
Description: Single oral dose
Study: NCT03157089

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Afatinib
Description: Film-coated tablet

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pembrolizumab
Description: Solution for infusion
Study: NCT04715490

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The Multimedia Symptom Management Program Intervention
Description: The program is composed of two parts: 1) a face-to-face presentation about the contents of the program, and 2) structured telephone support. The first part of the program will be conducted in the cardiology outpatient department. Participants will be instructed to read a HF handbook.~The second part of the program, structured telephone support, allowed the nurses to maintain contact with the participants in order to follow their progress. The participants will be scheduled to receive eight telephone coaching calls over a 3-month period.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Control group
Description: The control group will be provided with the HF handbook at the beginning of the 3-month period, and also will be received usual care, which included medical consultations, and two telephone calls.
Study: NCT02052362

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/r/ABT-267
Description: ABT-450, ABT-267 and ritonavir

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-450/r/ABT-267
Description: ABT-450, ABT-267 and ritonavir
Study: NCT00932256

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: STAHIST NDC #58407-536-01
Description: Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
Study: NCT02842866

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Description: 0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined
Description: 0.5 mL, Subcutaneous (SC), single dose on Day 0.
Study: NCT02419872

Intervention type: DRUG
Intervention: Marketed antagonists
Description: Medication for each patient is determined by the physician based on the patient's individual clinical profile and in accordance with the approved indication and label of the prescribed drug
Study: NCT00941928

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Epratuzumab
Description: 360 mg/m\^2 once a day by vein on Day -4, Day -1 and Days 3, 6, 10, 13 and 17.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 25 mg/m\^2 once a day by vein on Day -6 through Day -2 over 30 minutes.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 60 mg/kg once a day by vein on Days -5 and -4 over 2 hours.
Study: NCT00671034

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study: NCT04055532

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Intervention type: OTHER
Intervention: Neuraceq
Description: Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
Study: NCT00941928

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mesna
Description: 12 mg/kg by vein 5 times per day on Days -5 and -4 over 15 minutes.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Infusion of NK cells
Description: Transplant of Haploidentical NK cells by vein on Day 0.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Interleukin-2
Description: Subcutaneous injections three times a week for 9 doses on Days 0 to 21.
Study: NCT05460884

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Seaweed extract LD and white bread
Description: 109g of white bread with 0.5g of seaweed extract

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Seaweed extract HD and white bread
Description: 109g of white bread with 1g of seaweed extract

Intervention type: DIETARY_SUPPLEMENT
Group type: SHAM_COMPARATOR
Intervention: White bread
Description: 109g of white bread
Study: NCT03817528

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ITI-007
Description: ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
Study: NCT02130609

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Skintel
Study: NCT04054297

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: High GI/SFA diet
Description: Subject will adhere to a 2 week high GI/SFA diet.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Low GI/SFA diet
Description: Subject will adhere to a 2 week low GI/SFA diet.
Study: NCT01267279

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zoledronic acid
Description: Zoledronic acid per protocol

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT02445469

Intervention type: OTHER
Group type: OTHER
Intervention: MRI exam of the brain
Description: MRI exam of the brain

Intervention type: OTHER
Group type: OTHER
Intervention: MRI exam of the brain
Description: MRI exam of the brain

Intervention type: OTHER
Group type: OTHER
Intervention: MRI exam of the brain
Description: MRI exam of the brain

Intervention type: OTHER
Group type: OTHER
Intervention: MRI exam of the brain
Description: MRI exam of the brain
Study: NCT00671034

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mercaptopurine
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IV, IT, or PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methotrexate
Description: Given IV, IT, or PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegaspargase
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pegaspargase
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacological Study
Description: Correlative studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pharmacological Study
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Given IV or PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: Given IV or PO

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiation Therapy
Description: Some patients undergo RT

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Radiation Therapy
Description: Some patients undergo RT

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Thioguanine
Description: Given PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Thioguanine
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine Sulfate
Description: Given IV

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vincristine Sulfate
Description: Given IV
Study: NCT03403582

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Raspberries
Description: 250g frozen whole red raspberries
Study: NCT02274571

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TSEC (Tissue-selective estrogen complexes)
Description: Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: TSEC (Tissue-selective estrogen complexes)
Description: Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo
Description: non active

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: non active
Study: NCT01626924

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 2-Iminobiotin
Description: 2-Iminobiotin is formulated as a 0.75 mg/ml isotonic, iso-osmotic, saline solution with a pH of 4. It is administered as a solution for I.V.infusion through a central catheter. Six pulse doses will be given in 20 hours. Dosage will starts with 0.2 mg/kg/dose, but may be adapted during the study.
Study: NCT01169129

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: surgery
Description: resection of brain metastases

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: radiosurgery
Description: radiosurgery to brain metastases
Study: NCT03006380

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxytocin
Description: Ecbolic used to reduce blood loss

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxytocin
Description: Ecbolic used to reduce blood loss
Study: NCT03776747

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prone hyperpolarized 3 helium gas scan
Description: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Study: NCT03965689

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pevonedistat
Description: Given IV
Study: NCT01219868

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Physician-nurse team supervision
Description: Physician-nurse team will supervise patient's flow in the ED
Study: NCT01921010

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Niaspan
Description: See Arm Description

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: See Arm Description
Study: NCT02336295

Intervention type: OTHER
Group type: OTHER
Intervention: Food Frequency Questionnaires
Description: filling a Food Frequency Questionnaires
Study: NCT03711175

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Subscapularis repair
Description: Utilizing fiberwire, high tensile strength suture

Intervention type: DEVICE
Group type: OTHER
Intervention: Shoulder implant
Description: Reverse shoulder arthroplasty device

Intervention type: DEVICE
Group type: OTHER
Intervention: Shoulder implant
Description: Reverse shoulder arthroplasty device