An observational study in Lumpectomy, sponsored by The Cleveland Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The Cleveland Clinic · Observational
The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is FDA approved and indicated for cutting and coagulation of soft tissue during surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The device includes a coated electrode at the distal end of a rotatable and extendable shaft (telescope) which delivers monopolar radiofrequency energy for cutting and coagulation of tissue. These devices enable the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (ESU) to the operative site for the desired surgical effect. The integrated LED-based illumination allows the user to turn on or off the illumination. The integrated smoke evacuation tubing enables the user to evacuate smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
The Photon Blade 3 integrates localized surgical field illumination, simultaneous electrosurgical dissection, and active smoke evacuation. By improving visualization at the point of dissection and reducing smoke plume accumulation, surgeons perform more precise tissue dissection and hemostasis. The Photon Blade 3 device is FDA approved and being used in standard clinical care at Cleveland Clinic per its intended use. Utilization of the Photon Blade 3 expands feasibility of hidden scar lumpectomy approaches without compromising tissue handling. Cosmetic outcome after lumpectomy significantly influences patient satisfaction, body image, and quality of life. Reduced tissue trauma, optimized hemostasis, and improved control of the resection cavity translate into preservation of native breast contour, potentially leading to lower incidence of fat necrosis with less thermal injury, and more discrete scar placement.
The overall goal of this study is to assess the clinical performance and safety of the Photon Blade 3 illuminated electrosurgical device with integrated smoke evacuation, including patient reported outcomes, incorporation of oncoplastic techniques, and surgical field optimization. This study allows for the collection of data from cases where the device is already being used in standard clinical care in accordance with its FDA approved indication.
The Cleveland Clinic is the lead sponsor of 832 studies on the registry; 120 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
lumpectomy for benign or atypical disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Degree of clinical performance assess at the time of surgery by the operative success rate and occurrence of intraoperative complications.
Operative success determined by whether target lesion was excised.
Time frame: time of surgery
Postoperative complication rate assessed by the occurrence of pre-specified AE's at 3 days post-op, 2 weeks post-op, 45 days post-op and 90 days post-op.
The pre-specified AE's are seromas, hematomas, wound dehiscence and surgical site infections requiring antibiotics.
Time frame: up to 90 days post-op
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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