[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05975372":3,"trial-entities:NCT05975372":103,"trial-summary:NCT05975372":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":53,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":14,"eligibility_criteria":68,"std_ages":74,"locations":77,"central_contacts":97,"overall_officials":100,"references":101,"see_also_links":102},"NCT05975372","67363","Blossom® Smart Expander Device for Tissue Expander\u002FImplant-Based Breast Reconstruction","RECRUITING","2028-07","2026-06","2026-06-30","2023-11-17","Stanford University","OTHER",true,"The conventional breast tissue expander used for breast reconstruction\u002F augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander\u002Fimplant-based breast reconstruction\u002F augmentation compared to standard tissue expansion methods.","All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and opting for 2-staged tissue expander\u002Fimplant-based breast reconstruction or augmentation will be given the option of study enrollment. Consenting patients will be enrolled and randomized 1:1 to undergo standard 2-staged breast reconstruction\u002F augmentation with conventional tissue expansion (control) or with application Blossom Smart Expander Technology (intervention) in the first stage reconstruction (tissue expansion).\n\nThe intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.\n\nA Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom Syringe Assist device, will be inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation.\n\nPostoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.",[18,19],"Tissue Expansion","Implant Based Breast Reconstruction",[21,22],"Implant based breast reconstruction","Tissue expansion","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},20,"ESTIMATED",[31,40],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Blossom tissue expander","Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction\u002F augmentation.",[33],[37,38,39],"Blossom smart expander device","Marz blossom syringe assist device","Blossom syringe assist device",{"type":32,"name":41,"description":42,"armGroupLabels":43},"Standard tissue expansion","Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction\u002F augmentation.",[41],[45,49],{"measure":46,"description":47,"timeFrame":48},"Time until completion of tissue expansion","The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.","Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.",{"measure":50,"description":51,"timeFrame":52},"Incidence of complications","Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and\u002F or device malfunction, etc. will be monitored and recorded in each study arm.","Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)",[54,58,61],{"measure":55,"description":56,"timeFrame":57},"Patient satisfaction (BreastQ)","Patient satisfaction will be assessed using the validated BreastQ survey.","Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).",{"measure":59,"description":60,"timeFrame":57},"Patient satisfaction (device specific survey)","Patient satisfaction will be assessed using a device-specific survey.",{"measure":62,"description":63,"timeFrame":64},"Pain associated with tissue expansion","Pain will be assessed using a study-specific survey.","Patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).","ALL","18 Years","65 Years",{"inclusion":69,"exclusion":71,"raw_text":73},[70],"Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander\u002F implant-based breast reconstruction will be approached for potential enrollment in the study.",[72],"Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.","Inclusion Criteria:\n\n* Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander\u002F implant-based breast reconstruction will be approached for potential enrollment in the study.\n\nExclusion Criteria:\n\n* Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":94},"Stanford Hospital and Clinics","Palo Alto","California","94304","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Dung H Nguyen, MD, PharmD","CONTACT","(650) 725-2766","nguyendh@stanford.edu",{"name":91,"role":87,"phone":92,"email":93},"Elizabeth Tadevosyan, BS","818-269-1950","etadyan@stanford.edu",{"lat":95,"lon":96},37.44188,-122.14302,[98,99],{"name":86,"role":87,"phone":88,"email":89},{"name":91,"role":87,"phone":92,"email":93},[],[],[],{"nct_id":4,"conditions":104,"biomarkers":107},[105,106],"Augmentation Mammoplasty","Mammoplasty",[],{"nct_id":4,"found":14,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This study is an interventional study with 20 participants. Participants will be randomly assigned to either receive the Blossom® Smart Expander or standard tissue expansion.","completed","Blossom® Smart Expander Device for Breast Reconstruction","This study is looking at a new way to expand breast tissue for reconstruction or augmentation. If you're having two-stage, implant-based breast reconstruction, you might be able to join. The study compares the standard method of tissue expansion, which involves weekly or biweekly saline injections, with a new device called the Blossom® Smart Expander. This device aims to expand breast tissue slowly and continuously without frequent injections. Researchers want to see how long it takes to complete tissue expansion with each method and track any complications until the expander is removed, which is expected around 6 months after the first surgery. This study is open to women aged 18 to 65 who are having non-cancer related breast reconstruction or augmentation.","You will be monitored for complications until the tissue expander device is removed during the second stage surgery, which is approximately 6 months after the first surgery.",120,"You would have surgery to place the expander, followed by weekly follow-up appointments until expansion is complete and surgical scars stabilize. You will also have a second surgery to exchange the expander for a permanent implant.","Not stated in the trial record.",[],"v2"]