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. Blue®M 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 therapy's 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 mg/mL 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 observing the use and performance of the Galvanize Pulsed Electric Field (PEF) technology in real-world settings for patients with soft tissue lesions. The study aims to understand how often and how well the PEF technology is used, monitor safety outcomes, and provide information to improve future versions of the device. This observational registry includes patients who have undergone or are scheduled to undergo PEF ablation. Participants will receive PEF ablation treatment according to their institution's standard care practices. The study follows patients either prospectively or retrospectively, with a total follow-up period of two years starting from their PEF procedure date. Up to 200 patients across the US will be enrolled, and their treatments will be monitored but not altered by the study. During the study, participants will be followed according to their usual care plans, with researchers collecting information on the type of anesthesia used, the target location and size of the PEF treatment area, and any serious or unexpected adverse events within 30 days after the procedure. The study will track outcomes through imaging and standard follow-up visits as determined by the treating physician. Participants will be involved for up to two years to gather long-term safety and performance data on the device.

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 combination drug that forms a hydrogel at the injection site, for treating superficial lipoma. The study aims to assess its safety, how well it works, and how the body processes it. This includes a dose-escalation phase to find the maximum tolerated dose and a comparison phase to evaluate its bioavailability against the FDA-approved Kybella injection for submental fullness or lipoma treatment. Part I is a randomized, double-blind, placebo-controlled study where participants receive Ronkyla Plus or placebo injections every 28 days for up to six treatments, with doses depending on lipoma size. They stay in the hospital for monitoring after the first treatment and return for safety checks on Days 8 and 29. Part II is an open-label study where eligible participants receive a single dose of Ronkyla Plus at the maximum tolerated dose or Kybella at the approved maximum dose, followed by detailed pharmacokinetic blood sampling over 16 days. After this period, additional treatments are available for further lipoma clearance or submental fullness improvement. Participants will have regular hospital visits for safety evaluations, blood tests, and physical assessments during both study parts. In Part I, safety is monitored over seven months, while Part II includes a 16-day pharmacokinetic assessment and one month of safety follow-up. Researchers will measure adverse events, changes in vital signs, blood tests, and lipoma size and appearance. Participants will also rate injection site pain. The study includes a long-term monitoring period and possible additional treatments for participants in the Ronkyla Plus and Kybella groups.

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.

This research focuses on patients diagnosed with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), evaluating treatments based on risk categories: low, intermediate, and high risk. The study aims to estimate survival rates, find safe and effective dosages of certain drugs, and explore how the body's processing of medicines relates to treatment effects. It also investigates various outcomes such as tumor control, side effects, genetic tumor features, and cardiovascular health among children and young adults. Participants will receive treatments tailored to their risk and tumor characteristics. Surgery to remove the tumor is standard for all risk groups. Radiation therapy is given to those with positive tumor margins, usually starting 3 to 6 weeks after surgery and lasting 5 to 6 weeks. Intermediate- and high-risk patients may receive chemotherapy drugs including ifosfamide, doxorubicin, pazopanib, and for high-risk patients, selinexor. Maintenance therapy with pazopanib for six months follows consolidation chemotherapy and radiation as appropriate. Some patients may have delayed surgery or additional chemotherapy cycles before surgery. During the study, participants will undergo regular monitoring including evaluations of tumor status, side effects, heart and lung function, and laboratory tests. Researchers will study survival outcomes, treatment side effects, drug levels in the body, and tumor genetic changes using advanced sequencing methods. The study follows participants for multiple years to measure event-free survival and to determine safe dosing levels of selinexor. Close observation continues after treatment to watch for tumor recurrence and long-term health effects.

This research aims to compare three imaging techniques—whole body magnetic resonance (MR) imaging, whole body positron emission tomography (PET)/MR imaging, and, if available, PET/computed tomography (CT) imaging—in 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 Dupuytren's 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.

Researchers are evaluating a new imaging agent called [89Zr]DFO-starPEG in people with solid tumors. This first-in-human pilot study aims to gather early data on how this agent is taken up by tumors and the body, as well as its safety and radiation exposure. The goal is to support future use of this agent to help visualize how certain cancer treatments might accumulate in tumors. Participants receive a single intravenous microdose of [89Zr]DFO-starPEG. They are divided into two groups: one group undergoes multiple whole-body PET scans at several time points up to 9 days after injection, while the other group has a single PET scan between 5 and 9 days after injection. Urine and blood samples are also collected for additional studies. During the study, participants will be monitored for any side effects for about one week after the injection. Researchers will assess how much of the agent accumulates in tumors compared to normal tissue, measure radiation doses, and record any adverse events. The total participation time involves imaging and follow-up visits over approximately 9 days.