Lipoma

The trial focuses on improving soft tissue healing around dental implants, which is crucial for long-term success and aesthetics. Researchers are studying the use of topical oxygen therapy applied around customized healing abutments to better understand its effect on tissue regeneration, including linear and volumetric changes. This phase 4 study aims to provide clinical evidence to guide dental professionals in enhancing implant soft tissue management. Participants will undergo a thorough preoperative assessment including medical history, clinical and radiographic evaluations, and oral hygiene instruction before second-stage implant surgery. During surgery, a customized PEEK healing abutment is placed on the implant. BlueM oral gel, which delivers topical oxygen, is applied around the healing collar immediately after placement and continued twice daily for 7 days. Standard postoperative care including chlorhexidine mouthwash and pain management is provided. Participants will be monitored with clinical evaluations at baseline, day 7, and day 21 to assess soft tissue changes, pain, wound healing, and clinical photographs. The main outcomes measured are soft tissue dimensional changes and the Pink Esthetic Score at baseline, 3 months, and 6 months post-treatment. Secondary outcomes include postoperative pain and wound healing assessments at days 1, 3, and 10. The total participation period covers these follow-ups to evaluate the therapys impact.

Lipoma is a common, slow-growing tumor made of fat tissue. People seek treatment because of concerns about its growth, appearance, or pressure effects. Surgery is the usual removal method but can cause bleeding, infection, scarring, and recurrence. Other treatments like liposuction, laser, and medicines have been used. This research evaluates Embella, a synthetic deoxycholic acid injection, as a new treatment option for superficial lipomas. Participants will receive injections of Embella, a 10 mgmL deoxycholic acid solution, directly into the lipoma using a small syringe and needle. Each treatment involves injecting 0.1 or 0.15 mL per square centimeter of the lipoma, with a maximum of 2 cc per session. Injections occur at the start day 0, and additional touch-ups may be given at weeks 4 and 8 if needed, up to three total treatments. During the study, participants will be monitored through visits up to week 16. Researchers will measure changes in lipoma volume and size, patient satisfaction, and the need for further injections or surgery. Safety will be checked by assessing any side effects at several visits. The goal is to understand how safe and effective Embella injections are for reducing superficial lipomas.

Researchers are studying the effectiveness of multilayered platelet-rich fibrin PRF membrane compared to the gold standard connective tissue graft CTG for improving gum tissue around dental implants in the front of the mouth. The study focuses on achieving a good biological seal to protect implants and support esthetic outcomes, particularly in the anterior region where appearance is important. This research aims to explore whether PRF membrane offers benefits similar to CTG without added patient morbidity during the healing period after the second stage of implant surgery. Participants will receive either a dental implant combined with a multilayered PRF membrane or a dental implant with a connective tissue graft. Both groups will have implants placed at the subcrestal level following standard procedures, including local anesthesia, incision, flap reflection, and osteotomy. About four months after implant placement, a healing abutment will be positioned with sutures to secure the tissues. The PRF membrane is stabilized using the healing abutment to prolong exposure to growth factors, and the study compares these two approaches during the healing phase of the second-stage surgery. Participants will be assessed for peri-implant soft tissue thickness at 6 weeks and at 3 and 6 months after treatment. Other measurements include the width of keratinized tissue around the implants at baseline, 3, and 6 months, marginal bone loss at 6 months, and patient satisfaction using a visual scale at baseline, 2 weeks, and 6 months. The study involves regular evaluations of tissue healing and implant support over a 6-month period, with safety and effectiveness monitored throughout the process.

Researchers are observing the use and performance of Galvanize Pulsed Electric Field PEF technology in treating soft tissue lesions in a real-world setting. This multi-center registry study aims to answer key questions about how PEF technology is used, its performance, and safety outcomes to help develop future device generations. Up to 200 patients who undergo or have undergone PEF procedures will be enrolled across the United States. Participants receive the PEF ablation procedure following their institutions standard care practices. The study includes both prospective enrollment, where patients will be followed for 2 years after the PEF procedure, and retrospective enrollment, where patients who already had the procedure are followed longitudinally. This observational registry does not involve experimental treatment but monitors routine clinical use of the device. During the study, participants will be monitored according to their usual care schedules, with follow-up visits as determined by their physicians. Researchers will collect information on anesthesia type used during the PEF procedure, target location and size of the ablation, and track any serious or unexpected adverse events within 30 days after treatment. The total follow-up duration for participants is 2 years, allowing long-term assessment of safety and device performance.

This research aims to collect detailed information on the use of cryoablation procedures in children with soft tissue and bone lesions. Cryoablation is a minimally invasive technique that uses image guidance to insert specialized needles or probes into lesions, applying cycles of freezing and thawing to destroy tissue. While this method is well established for adults, especially in treating kidney tumors, its use in children is still new and not well documented. The study will audit the range of applications, success rates, safety, complications, and effectiveness of cryoablation in the pediatric population. The study involves children undergoing cryoablation therapy for benign soft tissue lesions. Cryoablation uses a mechanized unit connected to probes that freeze and thaw the targeted tissue via highly pressurized gases. This process causes tissue destruction both mechanically and through immune responses. The registry collects data from multiple centers in the UK and Europe, gathering standardized information about each procedure. Data will be anonymized and entered into a web-based system for analysis. The study is open and non-controlled, focusing on repeat treatments as determined by clinical decisions. Participants will be followed for up to five years to monitor outcomes such as changes in lesion size, symptom changes, procedure failures, and any complications within two years after treatment. The registry aims to provide evidence on safety, efficacy, and best practice for pediatric cryoablation. Data will be analyzed collectively while remaining owned by individual hospitals. This will help improve treatment guidance and support future clinical trials if needed. The total participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating Ronkyla Plus, a new drug that forms a hydrogel at the injection site, for treating superficial lipoma. This study aims to assess the safety, effectiveness, and how the drug moves through the body. It includes a Part I dose-escalation phase to find the highest tolerated dose, and a Part II phase to compare Ronkyla Plus to an FDA-approved injection called Kybella. In Part I, participants receive injections of Ronkyla Plus or placebo based on lipoma size, up to 10 mL per treatment, every 28 days for up to six treatments. Safety is closely monitored, including a 3-hour hospital stay after the first treatment and follow-up visits on Days 8 and 29 of each cycle. Part II involves an open-label comparison where subjects receive a single dose of Ronkyla Plus at the maximum tolerated dose or Kybella at its approved dose, followed by a 16-day pharmacokinetic assessment with scheduled blood sampling and hospital visits. Participants will undergo clinical assessments including physical exams, blood tests, and monitoring for side effects throughout the study. In Part II, detailed blood sampling occurs over 16 days to study drug levels. Additional treatments may be offered after assessment for further clearance of lipomas or submental fullness. The study measures include adverse events, changes in vital signs and lab tests, lipoma clearance rates, and participant satisfaction. Total study duration includes up to seven months for Part I and one month for Part II.

Lipomas are common benign tumors made of mature fat tissue, often removed for cosmetic reasons or because they press on nearby structures. This research explores subcutaneous injections of cooled normal saline as a possible nonsurgical treatment for lipomas. The study also includes an additional group to assess warmed normal saline injections, aiming to find a more comfortable alternative to fat-freezing devices applied on the skin. Participants will receive injections directly into their lipomas using either cooled or warmed sterile sodium chloride mixed with lidocaine and epinephrine. The volume of the injected solution will be three times the estimated lipoma size. After the injection, the area will be gently massaged to distribute the solution evenly. This study includes multiple treatments spaced about four weeks apart. During the study, researchers will monitor pain and redness fifteen minutes after each injection, as well as changes in lipoma size after multiple treatments and up to twelve weeks following the last injection. Participants may receive up to four treatments, and the study is designed to evaluate safety and effectiveness over this period. The total participation duration varies, with ongoing assessments throughout the treatment and follow-up phases.

Researchers are studying treatment strategies for patients diagnosed with non-rhabdomyosarcoma soft tissue sarcoma NRSTS, focusing on different risk groups including low, intermediate, and high-risk categories. The study evaluates combinations of surgery, chemotherapy drugs ifosfamide, doxorubicin, pazopanib, selinexor, and radiation therapy to assess outcomes such as event-free survival, maximum tolerated dose, and treatment-related toxicities. Additional research goals include understanding drug pharmacokinetics, tumor molecular features, and long-term health effects related to cancer and its treatment. Participants receive risk-adapted therapies based on their tumor grade, size, and surgical margins. Low-risk patients may undergo surgery alone with monitoring, while intermediate- and high-risk groups receive combinations of chemotherapy, radiation therapy, and maintenance treatment with pazopanib. Radiation is delivered daily over 5 to 6 weeks starting 3 to 6 weeks after surgery. Selinexor is studied for high-risk patients as an oral medication taken once on day 3. Treatment plans may include induction chemotherapy cycles, surgery timing, and consolidation therapies tailored to tumor resectability and molecular characteristics. Throughout the study, participants undergo regular assessments including imaging, pharmacokinetic sampling, and cardiac monitoring to evaluate treatment response and safety. Researchers measure event-free survival over up to 9 years and determine recommended dosing levels. Tumor samples may be analyzed using advanced genetic and molecular tools. Participants are monitored for side effects, tumor recurrence, and overall health, with follow-up continuing for several years to capture long-term outcomes and treatment impacts.

This research aims to compare three imaging techniqueswhole body magnetic resonance MR imaging, whole body positron emission tomography PETMR imaging, and, if available, PETcomputed tomography CT imagingin diagnosing tumors in children and young adults. The study focuses on assessing differences in sensitivity, specificity, and diagnostic accuracy among these imaging methods for solid tumors and certain leukemia cases with suspected focal lesions. The study is observational and involves participants with proven or suspected solid tumors.

Researchers are evaluating the effectiveness of percutaneous needle fasciotomy with or without corticosteroid injection for treating Dupuytrens contracture affecting the metacarpophalangeal MCP joints. This randomized controlled trial aims to compare these two treatment options in patients aged 45 to 99 years with this joint condition. The study is led by Regionshospitalet Silkeborg and is designed as a Phase 4 clinical trial with double masking. The study includes two treatment groups one group will receive percutaneous needle fasciotomy combined with corticosteroid injection Depo-Medrol, and the other group will receive the same fasciotomy combined with a saline injection as a placebo comparator. The fasciotomy procedure follows the Lermusiaux and Debeyre technique. Participants must have sufficient correction of the MCP joint during treatment, with less than 20 degrees passive extension deficit. Participants will be monitored for outcomes including the recurrence rate of contracture after two years. Assessments will focus on the correction of joint contracture, with follow-up visits to measure the effectiveness and safety of the treatments. The trial will also evaluate secondary outcomes related to joint function and patient well-being over the study period ending in March 2030.