Ablative Techniques for Endometriosis

Overseen By Devin Namaky, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: TriHealth Inc.

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 0 days

141 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares three techniques that use energy to treat endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus, causing pain. The treatments being tested are the Argon Beam Coagulator (also known as Argon Plasma Coagulation or APC), CO2 Laser, and Diathermy. Women scheduled for surgery to remove endometriosis lesions due to symptoms like pelvic pain or painful periods are suitable candidates for this trial. The goal is to determine which technique most effectively removes the problematic tissue. As an unphased trial, this study allows participants to contribute to valuable research that could enhance treatment options for endometriosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these ablative techniques are safe for treating endometriosis?

Research has shown that the three treatments under study—Diathermy, CO2 Laser, and Argon Beam Coagulator—are generally safe based on past studies.

For Diathermy, studies suggest it can be safely used in surgery with minimal risk to nearby tissues. It has effectively treated endometriosis, focusing on managing pain and infertility safely.

CO2 Laser treatment has precisely removed endometriosis lesions with minimal damage to surrounding tissue. Research indicates little blood loss and short operation times. Some side effects, like vaginal pain, were noted but were similar to those in groups not receiving the treatment.

Argon Beam Coagulator has also been shown to be safe. It uses a neutral beam of argon gas to treat endometriosis. Studies suggest it is safe and may improve healing rates, preserving tissue better than some other methods.

Overall, these treatments are generally well-tolerated, with studies showing they are safe options for managing endometriosis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these ablative techniques for endometriosis because they offer precision and reduced tissue damage. Unlike standard treatments, which often involve hormone therapy or extensive surgery, the Argon Beam Coagulator, CO2 Laser, and Diathermy provide targeted destruction of endometrial tissue with minimal impact on surrounding areas. The CO2 Laser is particularly noteworthy for its ability to deliver focused energy, enhancing precision. Meanwhile, the Argon Beam Coagulator stands out for its rapid coagulation capability, which can help in controlling bleeding. These features promise to improve treatment outcomes and recovery times, offering new hope for those affected by endometriosis.

What evidence suggests that this trial's treatments could be effective for endometriosis?

This trial will compare three ablative techniques for treating endometriosis: diathermy, CO2 laser, and the argon beam coagulator. Research has shown that diathermy, which uses electric heat to remove tissue, effectively treats mild to moderate endometriosis. Studies comparing it with helium coagulation found no significant difference, suggesting diathermy is a reliable treatment option.

CO2 laser treatment is another choice in this trial. Research indicates it effectively relieves pain, improves quality of life, and can boost fertility. It is considered as effective as other treatments for endometriosis.

The argon beam coagulator, another treatment option in this trial, uses a type of gas to cut and seal tissue and has shown promise in treating endometriosis. Studies suggest it is safe and can effectively manage the condition. Each of these treatments offers different benefits, and choosing the right one may depend on individual needs. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adult women aged 18 or older who are scheduled for robotic assisted or laparoscopic surgery to remove endometriosis lesions due to pelvic pain symptoms. It's not open to pregnant women at the time of enrollment or surgery.

Inclusion Criteria

I am a woman over 18 planning surgery for pelvic pain or endometriosis.

Exclusion Criteria

Known pregnancy at enrollment or at the time of the excision surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablative procedures using different energy sources to treat endometriosis

0 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pelvic pain

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Argon Beam Coagulator
• CO2 Laser
• Diathermy

Trial Overview The study compares three different techniques used in surgery to destroy endometriosis tissue: Diathermy, CO2 Laser, and Argon Beam Coagulator. The goal is to find out which method is most effective.

How Is the Trial Designed?

Group I: Diathermy Active Control 1 Intervention

Group II: CO2 Laser Active Control 1 Intervention

Group III: Argon Beam Coagulator Active Control 1 Intervention

Argon Beam Coagulator is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Argon Plasma Coagulation for:

• Gastrointestinal bleeding
• Endoscopic hemostasis
• Lesion coagulation

Approved in United States as Argon Beam Coagulator for:

• Surgical hemostasis
• Solid organ injury
• Endometriosis treatment

Approved in Canada as Argon Plasma Coagulation for:

• Gastrointestinal bleeding
• Endoscopic hemostasis

Approved in Japan as Argon Beam Coagulator for:

• Surgical hemostasis
• Solid organ injury

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Published Research Related to This Trial

Laser treatment, including CO2, argon, and Nd:YAG lasers, offers a less invasive option for managing mild to moderate endometriosis during laparoscopic diagnosis, potentially reducing the need for major surgery and long-term medication.

This approach allows for immediate intervention, which can help avoid delays in conception for women diagnosed with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The present and future application of lasers to the treatment of endometriosis and infertility. Keye, WR.[2013]

The argon laser effectively ablated endometrial implants in a study involving five rabbits, demonstrating its potential as a treatment for endometriosis.

Histological analysis showed complete removal of the endometriosis with minimal damage (only 0.25 mm) to the surrounding tissue, suggesting a safer option compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the argon laser in the treatment of experimental endometriosis. Keye, WR., Matson, GA., Dixon, J.[2019]

In a study of 55 patients with endometriosis treated with laparoscopic argon beam coagulation, 72.5% experienced improvement in pelvic pain post-surgery, indicating its efficacy for pain management.

The procedure also led to a 28% early pregnancy rate among women who had previously struggled with infertility, suggesting it may be beneficial for reproductive outcomes as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Use of Argon Beam Coagulator in the Management of Endometriosis Daniell, JF., McTavish, G., Kurtz, BR., et al.[2019]

In in-vitro studies, argon beam coagulation demonstrated a maximum tissue necrosis depth of 2.4 mm and a diameter of 1.1 cm without causing perforations, even in sensitive areas like the colon and duodenum.

In clinical application involving 66 patients, the technique successfully achieved definitive hemostasis in 49 out of 50 cases of bleeding and completely removed residual adenoma tissue in all 11 patients, indicating its efficacy and safety as a treatment option in gastrointestinal endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation (APC) in gastroenterology: experimental and clinical experiences. Johanns, W., Luis, W., Janssen, J., et al.[2019]

A new surgical method using CO2 laser for treating pelvic endometriosis was performed on 54 patients, showing advantages like precision and a bloodless field during the procedure.

Out of 23 patients who attempted pregnancy after the surgery, 60.8% successfully conceived, indicating the potential effectiveness of this laser technique in improving fertility outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pelvic endometriosis by means of intraabdominal carbon dioxide laser. Chong, AP., Baggish, MS.[2017]

In a study involving 41 women, laparoscopic argon-enhanced electrosurgery was found to provide quick and safe hemostasis during the treatment of various types of endometriosis, with minimal damage to surrounding tissues.

The use of argon-enhanced coagulation improved surgical visibility by eliminating smoke and reducing tissue trauma, which may lead to less blood loss, shorter operating times, and better long-term surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon Beam Coagulator in Laparoscopic Gynecologic Surgery Kulakov, VI., Adamian, LV., Kiselev, SI., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3030779/

Use of Neutral Argon Plasma in the Laparoscopic ... Neutral argon plasma energy can be used as a multifunctional device that has vaporization, coagulation and superficial cutting capabilities with little ...

2. link.springer.com link.springer.com/article/10.1007/s00404-024-07477-3

Comparing the effects of argon plasma coagulation and ... This study aimed to evaluate the clinical efficacy and safety of argon plasma coagulation (APC) therapy and interferon therapy in patients with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1110569013000733

Argon beam coagulator versus cystectomy for ... Our study clearly demonstrated that the surgical management of endometrioma, with either ovarian cystectomy or argon beam coagulator vaporization causes a ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35284956/

Hybrid argon plasma coagulation (HybridAPC) versus ... Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/codi.14541

Argon plasma coagulation is an effective treatment for ... Seventy patients [90% with cervical cancer, 10% with endometrial cancer; mean age 51.93 ± 9.15 years; median RBG 3 (range 2–4)] received APC.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2018/3087603

Efficacy and Safety of Argon Plasma Coagulation for ... In conclusion, current literature indicated that APC therapy was an effective and safe strategy for hemorrhagic CRP, and large-scale prospective ...