Is NCT07385430 recruiting in Lebanon, NH?

Yes, NCT07385430 is currently recruiting participants at its Lebanon, NH location. This adults clinical trial is actively enrolling qualified participants.

How do I join the adults clinical trial in Lebanon?

To join this clinical trial in Lebanon, 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 Lebanon 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.

Adults Clinical Trial in Lebanon, NH

About This Adults Study in Lebanon

The primary goal of this study is to determine the safety and tolerability of LGW16-03, a novel nerve-labeling fluorophore, in participants undergoing open-field orthopaedic surgery. Secondary goals include: 1) identifying the lowest dose without adverse events that provides peak florescence imaging contrast, and 2) characterizing the pharmacokinetics of LGW16-03. Participants will receive a one-time intravenous infusion of the investigational drug (LGW16-03) prior to their planned surgery. Participants' vitals will be closely monitored and will have blood samples taken at regular intervals. Fluorescence images of their major nerve will be taken during surgery. Participants will have one study follow-up visit approximately 30 days after their surgery.

Sponsor: Eric R. Henderson

Who Can Participate

Inclusion Criteria

(All of the following criteria must be met by study participants to be eligible for study enrollment):

Scheduled and medically cleared for a standard of care, open-field (not endoscopic) surgical procedure wherein a major nerve will be exposed and visible to the imaging equipment.

Participants must be willing and able to provide informed consent for participation in the study and adhere to all study procedures.

Intact motor and sensory function in the nerve to be imaged, as determined by physical exam performed by the operating surgeon or clinician on the study team, including:

5/5 motor strength in relevant muscle groups.

Normal sensation on testing with a 5.07 Semmes-Weinstein filament or other valid testing method.

No documented history of neuropathy of any kind.

Age ≥ 18 years old.

Medical clearance for surgery provided by a supervising medical provider (surgeon or primary care provider).

Adequate renal function defined as creatinine clearance ≥ 60mL/min.

Adequate liver function:

Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN in patients with Gilbert's disease)

ALT and AST ≤ 2.5 x ULN if no active liver involvement or ALT and AST ≤ 5 xULN with active liver involvement

Albumin ≥3 g/dL

Adequate hematologic and clotting function:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

Platelet count ≥ 100 x 109/L

Hemoglobin ≥ 8 g/dL or ≥ 5.6 mmol/L

International Normalized Ratio (INR) ≤ 1.5 x ULN

No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence.

Exclusion Criteria

(Any of the following criteria would exclude a participant from study enrollment):

Pregnant or breastfeeding persons who are not willing to stop breastfeeding. Due to the unknown safety profile of LGW16-03 in humans, and the potential for fetal or neonatal exposure through transplacental transfer or breast milk, breastfeeding is not allowed throughout the study and until at least 60 days after last dose.

Nerve injury or dysfunction of any kind in the nerve to be imaged (e.g., diabetic neuropathy, multiple sclerosis, other neuropathy, traumatic nerve injury)

Peripheral vascular disease requiring management a vascular surgeon.

Prior surgery in the planned surgical region within the previous 365 days.

Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.

Current evidence of renal or liver disease.

History of fluorescein allergy.

Direct administration of a local anesthetic agent in the region of the nerve to be imaged that could affect the motor or sensory function of the target nerve.

Any other criteria deemed by the Principal Investigator that may prevent the participant from successfully completing the trial.

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 Lebanon?

Yes, this clinical trial (NCT07385430) has an active research site in Lebanon, NH 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.

Adults Treatment Options in Lebanon, NH

If you're searching for adults treatment options in Lebanon, NH, this clinical trial (NCT07385430) 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 Lebanon research site is actively enrolling participants for this clinical trial. You'll receive care from experienced adults 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 adults clinical trials near you to find additional studies recruiting in your area.

Adults Clinical Trial in Lebanon, NH

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No-Cost Care

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