Cirugía

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. A Study to Evaluate the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
   Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
    

2. A Study to Evaluate Support Services for Managing Urological Conditions

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess if men and women seeking care for urological diseases have interest in support services in conjunction with standard of care.

3. Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

4. A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy

   Jacksonville, Fla.

   The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.

5. A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

   Jacksonville, Fla.

   This study aims to compare postoperative pain levels between three (3) treatment groups, using the Numerical Rating Scale (NRS).

    

6. A Study to Evaluate Novel Nipple Reconstruction Technique Using Nipple Sharing of a Half-Split Nipple in Female-to-Male Transgender Chest-Wall Contouring

   Rochester, Minn.

   The purpose of this study is to describe a new surgical technique for nipple reconstruction in female-to-male transgender chest wall reconstruction and demonstrate its safety, patient satisfaction, aesthetic evaluation and complications. Subsequently, correlate these findings to assess overall surgical and clinical outcomes.

7. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

   Rochester, Minn., Jacksonville, Fla.

   Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

8. A Study to Evaluate Whether or Not Pelvic Peritonectomy Improves Quality of Life for Patients Regardless of Endometriosis Pathology?

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to investigate if complete pelvic peritonectomy is associated with improved quality of life in patients with chronic pelvic pain without histologic diagnosis of endometriosis as compared to patients with histologic diagnosis of endometriosis. 

9. A Study to Evaluate Vascularized Lymph Node Transfer Coverage

   Rochester, Minn.

   The purpose of this study is to investigate outcomes for all patients with upper or lower extremity lymphedema with lymph node transfer in a two stage procedure involving dermal regeneration followed by split thickness skin graft (STSG) and compared to patients only receiving STSG for wound coverage.

    

10. A Study to Evaluate Outcomes of Pectoralis Minor and Brachial Plexus Release

    Rochester, Minn.

    The purpose of this study is to to assess the clinical and radiographic outcomes of patients who have undergone shoulder arthroplasty.

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. A Study to Evaluate the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
   Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
    

2. A Study to Evaluate Support Services for Managing Urological Conditions

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess if men and women seeking care for urological diseases have interest in support services in conjunction with standard of care.

3. Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

4. A Study to Evaluate the Venn Ovarian CAncer Liquid Biopsy

   Jacksonville, Fla.

   The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.

5. A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty

   Jacksonville, Fla.

   This study aims to compare postoperative pain levels between three (3) treatment groups, using the Numerical Rating Scale (NRS).

    

6. A Study to Evaluate Novel Nipple Reconstruction Technique Using Nipple Sharing of a Half-Split Nipple in Female-to-Male Transgender Chest-Wall Contouring

   Rochester, Minn.

   The purpose of this study is to describe a new surgical technique for nipple reconstruction in female-to-male transgender chest wall reconstruction and demonstrate its safety, patient satisfaction, aesthetic evaluation and complications. Subsequently, correlate these findings to assess overall surgical and clinical outcomes.

7. A Study to Evaluate Whether or Not Pelvic Peritonectomy Improves Quality of Life for Patients Regardless of Endometriosis Pathology?

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to investigate if complete pelvic peritonectomy is associated with improved quality of life in patients with chronic pelvic pain without histologic diagnosis of endometriosis as compared to patients with histologic diagnosis of endometriosis. 

8. A Study to Evaluate Vascularized Lymph Node Transfer Coverage

   Rochester, Minn.

   The purpose of this study is to investigate outcomes for all patients with upper or lower extremity lymphedema with lymph node transfer in a two stage procedure involving dermal regeneration followed by split thickness skin graft (STSG) and compared to patients only receiving STSG for wound coverage.

    

9. A Study to Evaluate Outcomes of Pectoralis Minor and Brachial Plexus Release

   Rochester, Minn.

   The purpose of this study is to to assess the clinical and radiographic outcomes of patients who have undergone shoulder arthroplasty.

10. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

    Rochester, Minn., Jacksonville, Fla.

    Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.