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

Trial Summary

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 data supports the effectiveness of the treatment Ablative Techniques for Endometriosis?

Research shows that using the Argon Beam Coagulator for endometriosis treatment improved pain in 72.5% of women and helped 28% of women with infertility to conceive. Additionally, the argon laser completely removed endometriosis in an animal study, suggesting its potential effectiveness. ^{1 2 3 4 5}

How is the treatment using Argon Beam Coagulator, CO2 Laser, and Diathermy for endometriosis different from other treatments?

This treatment is unique because it uses advanced laser and coagulation techniques to precisely target and remove endometrial tissue with minimal damage to surrounding areas, reducing blood loss and improving visualization during surgery. It offers a less invasive option compared to major surgery and can be performed during diagnostic laparoscopy, potentially speeding up treatment and improving outcomes for pain and infertility. ^{1 2 3 4 6}

What is the purpose of this trial?

To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Use of Argon Beam Coagulator in the Management of Endometriosis [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The use of the argon laser in the treatment of experimental endometriosis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Argon Beam Coagulator in Laparoscopic Gynecologic Surgery [2019]

5. England pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation (APC) in gastroenterology: experimental and clinical experiences. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Management of pelvic endometriosis by means of intraabdominal carbon dioxide laser. [2017]