Is NCT06725030 recruiting in New Haven, CT?

Yes, NCT06725030 is currently recruiting participants at its New Haven, CT location. This open surgery clinical trial is actively enrolling qualified participants.

How do I join the open surgery clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Open Surgery Clinical Trial in New Haven, CT

About This Open Surgery Study in New Haven

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

Sponsor: MMI (Medical Microinstruments, Inc.)

Who Can Participate

Inclusion Criteria

At least 22 years of age

Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure

Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free-flap surgery of the breast or extremities and/or lymphovenous anastomosis surgery of the extremities

Investigator deems the candidate acceptable for free flap transfer surgery and/or lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU) Cohort Specific Pre- Operative Inclusion Criteria: Free Tissue Transfer Surgery: N/A Lymphovenous Anastomosis Surgery

Swelling of one limb that is not completely reversed by elevation or compression

Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system

At least one of the following positive quantitative measurements:

Volumetry differential between affected limb and contralateral limb must be at least 10% of the other

Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units

Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen

Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit). Pre-Operative

Exclusion Criteria

Patients who are incapable and/or unwilling to provide informed consent

Active systemic infection under treatment with intravenous antibiotics

Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion

Known history of significant bleeding, coagulopathy, or Von Willebrand's disease

Patients with implanted pacemaker

Planned vein graft

Currently receiving chemotherapy or radiation therapy

History of chronic kidney disease

History of chronic liver disease

Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes

Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator Cohort Specific Pre-Operative Exclusion Criteria: Free Tissue Transplant Surgery:

Patients with buried flaps

Multiple flaps planned for the procedure Lymphovenous Anastomosis Surgery:

Patients \> 75 years of age

Patients with prior lymphatic reconstruction surgery

Patients with venous edema (arising from increased capillary filtration)

Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure

Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema

Current infection in the affected limb

Patients who experience more than one episode of cellulitis in a six month period over the past two years

Current evidence or a history of malignancy within the past 6 months (if the participant has undergone cancer treatment, this must have been completed \> 6 months prior to enrollment)

Known iodine sensitivity

Patient's lymphatic disease is due to lipedema

Patients with bilateral lymphedema or lymphedema in multiple anatomical locations Intra Operative Exclusion Criteria:

Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest

The patient does not have at least one robotic stitch attempted during the index procedure

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT06725030) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Open Surgery Treatment Options in New Haven, CT

If you're searching for open surgery treatment options in New Haven, CT, this clinical trial (NCT06725030) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this clinical trial. You'll receive care from experienced open surgery specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all open surgery clinical trials near you to find additional studies recruiting in your area.

Open Surgery Clinical Trial in New Haven, CT

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