Clinical trials: Intraoperative
Hallux Valgus Deformity
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects.
- Trial name
- NCT03307837
- Testing
- CA-008
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Concentric Analgesics
Peritoneal Carcinomatosis
A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity.
- Trial name
- NCT04950166
- Testing
- pegsitacianine
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- OncoNano Medicine, Inc.
Intraoperative Bleeding
Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
This is a prospective, multicenter, randomized, controlled investigation. Subjects in which bleeding from the exposed parenchymal surface is observed intraoperatively following the ligature of vessels visible with the unaided eye…
- Trial name
- BARRIER (NCT01458561)
- Testing
- BioFoam Surgical Matrix, Gelfoam Plus
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- CryoLife, Inc.
Breast Cancer
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
- Trial name
- Pivotal (NCT00749931)
- Testing
- MarginProbe, Lumpectomy
- Where
- 21 sites in United States, Israel
- Volunteers
- 664 people
- Sponsor
- Dune Medical Devices
Hearing Loss
Intracochlear Potentials: Volta Study
Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months…
- Trial name
- CLTD5663 (NCT02852330)
- Testing
- SA16 research software, CS19 (1.6.2)
- Where
- 2 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Mild or Moderate Surgical Bleeding
A Study of Fibrocaps™ in Surgical Bleeding
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
- Trial name
- FINISH-3 (NCT01527357)
- Testing
- Fibrocaps, Gelatin sponge
- Where
- 48 sites in United States, Belgium and 2 more
- Volunteers
- 721 people
- Sponsor
- Mallinckrodt
Breast Neoplasm Female, Breast Cancer
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible.
- Trial name
- NCT04815083
- Testing
- Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System
- Where
- 7 sites in United States
- Volunteers
- 57 people
- Sponsor
- SBI ALApharma Canada, Inc.
Spinal Surgery
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml.
- Trial name
- NCT01251042
- Testing
- Sangvia
- Where
- Denmark
- Volunteers
- 51 people
- Sponsor
- Wellspect HealthCare
Parotid Neoplasm, Thyroid Neoplasms
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
- Conditions
- Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery
- Trial name
- NCT04420689
- Testing
- Bevonescein
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Alume Biosciences, Inc.
Bleeding Active
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
- Trial name
- CELSTAT (NCT02640235)
- Testing
- CELSTAT, Surgicel Original
- Where
- 25 sites in United States, Czechia and 2 more
- Volunteers
- 260 people
- Sponsor
- Baxter Healthcare Corporation
Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Endostapler Hemostasis Study
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from…
- Trial name
- NCT04149925
- Testing
- AEON Endostapler, Echelon Flex Powered Stapler
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lexington Medical Inc.
Cataract, Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome
An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.
- Trial name
- NCT00711347
- Testing
- DisCoVisc, Healon5
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Alcon Research
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Bilateral Middle Ear Effusion
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement.
- Trial name
- NCT02350998
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Otonomy, Inc.
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Parkinson
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS…
- Trial name
- INVENT (NCT03630302)
- Testing
- DBS
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Cataract, Corneal Astigmatism
ClarVista HARMONI Toric Trial With Intraoperative Exchange
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Cataract, Corneal Astigmatism, Aphakia
- Trial name
- NCT03054649
- Testing
- HARMONI® Modular Intraocular Lens System, Intraoperative optic exchange
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 44 people
- Sponsor
- ClarVista Medical
Osteoarthritis
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of…
- Trial name
- NCT02286739
- Testing
- TKA with "Verasense", TKA without "Verasense"
- Where
- 6 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Orthosensor, Inc.