Clinical trials: Surgical Margin
Breast Cancer
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.
- Trial name
- Polarhis (NCT05118568)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- SamanTree Medical SA
Breast Cancer
LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected…
- Trial name
- NCT02037269
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Lightpoint Medical Limited
Breast Cancer
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast…
- Trial name
- NCT05456373
- Testing
- ClearEdge device
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- LS BioPath
Dental Plaque
Train New Examiners Via Modified Gingival Margin Plaque
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
- Trial name
- NCT00758563
- Testing
- Fluoride, Triclosan/Fluoride
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Colgate Palmolive
Breast Neoplasms
The Breast Surgery EnLight and LightPath Imaging System Study
This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath…
- Trial name
- NCT02151071
- Testing
- EnLight, LightPath
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Lightpoint Medical Limited
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Breast Cancer
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria.
- Trial name
- NCT02313116
- Testing
- Interferometric Synthetic Aperture Microscopy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Diagnostic Photonics, Inc.
Peripheral Nerve Injuries
Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.
- Trial name
- NCT04572906
- Testing
- NTX-001
- Where
- 10 sites in United States
- Volunteers
- 51 people
- Sponsor
- Neuraptive Therapeutics Inc.
Breast Cancer
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard…
- Trial name
- RCT (NCT05113927)
- Testing
- Selene
- Where
- 10 sites in United States
- Volunteers
- 613 people, healthy volunteers welcome
- Sponsor
- Perimeter Medical Imaging
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Buccal Mucosa Cancer, Gingival Cancer
Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin.
- Trial name
- NCT03137953
- Testing
- Clinical Evaluation, Radiological Imaging
- Where
- India
- Volunteers
- 30 people
- Sponsor
- HealthCare Global Enterprise Ltd.
Glioblastoma
Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma
Part 1 (dose escalation, safety, and preliminary efficacy) Part 1 is a non-randomised, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection.
- Trial name
- OPTICAL (NCT07356973)
- Testing
- irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM
- Where
- United Kingdom
- Volunteers
- 147 people
- Sponsor
- CRISM Therapeutics LTD
Surgical Wound
A Post-Market Clinical Investigation on Mepilex Border Post-Op
This is a retrospective, observational (non-interventional), single-arm, single-centre, post-market clinical investigation designed to verify clinical performance and safety of Mepilex Border Post-Op when used according to…
- Trial name
- ARCTIS (NCT04994145)
- Where
- Belgium
- Volunteers
- 560 people
- Sponsor
- Molnlycke Health Care AB
Jaw, Edentulous, Partially
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla.
- Trial name
- NCT00748241
- Testing
- Astra Tech Fixture ST
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Blepharitis
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels
- Trial name
- NCT00629941
- Testing
- AzaSite®
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
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
BCC - Basal Cell Carcinoma, BCC
CellFX Treat & Resect Low-Risk BCC Feasibility Study
This prospective, multicenter, study is designed to evaluate the safety and effectiveness of the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and nodular) for complete histological clearance of…
- Conditions
- BCC - Basal Cell Carcinoma, BCC, Excision Margin
- Trial name
- NCT04918381
- Testing
- CellFX System
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pulse Biosciences, Inc.
Breast Cancer
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S.
- Trial name
- IMPACT (NCT07616856)
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Prostatic Neoplasms
PRIME - PRostate Imaging for Margin Evaluation
This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine tumour margin status.
- Trial name
- PRIME (NCT02151097)
- Where
- United Kingdom
- Volunteers
- 7 people
- Sponsor
- Lightpoint Medical Limited
Breast Cancer
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion…
- Trial name
- NCT01699867
- Testing
- Optical coherence tomography
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Diagnostic Photonics, Inc.